Search Results Within Category "Cancer"
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Connect® Myeloid Disease Registry
clinicaltrials@northshore.org
All
18 years and over
NCT01688011
Inclusion Criteria:
• Patients must be able to provide written informed consent form (ICF)
• Must be willing and able to complete baseline and follow-up HRQoL instruments, for which patients must be proficient in either English or Spanish
• AML patients must be at least 55 years of age at the time of informed consent.
• MF, ICUS, and MDS patients must be at least 18 years of age at the time of informed consent. Newly diagnosed Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML) patients:
• Newly diagnosed primary or secondary disease. To be considered "newly diagnosed", a patient's confirmed diagnosis must be made no more than 60 days prior to the date of consent signature. (An additional 5-day window [i.e., up to 65 days prior to the date of ICF signature] may be allowed in special circumstance upon sponsor approval)
• Cohort assignment confirmed by central eligibility review. Cohort assignment must also be confirmed by the site. Myelofibrosis (MF) patients:
• Patients who initiated their first active systemic treatment for MF and/or MF-related cytopenias within 90 days prior to the date of consent signature. This cohort allows the enrollment of subjects with a diagnosis of Myelodysplastic/Myeloproliferative overlap syndromes (MDS/MPN overlap syndrome).
• Cohort assignment is confirmed by the site. Central eligibility review is not required. Treated Lower-Risk Myelodysplastic Syndromes (LR-MDS) patients:
• Patients who have initiated first active treatment regimen containing at least one non-ESA therapy, within 90 days prior to ICF
• Cohort assignment is confirmed by site. Central eligibility review is not required. Luspatercept treated patients:
• Patient must have been at least 18 years of age at the start of luspatercept.
• Among LR-MDS patients, patient must have initiated luspatercept on or after September 1, 2023, must be ESA-naïve and luspatercept must be the first active treatment (as monotherapy or part of a treatment regimen) for their disease.
• Among all other myeloid malignancies, there is no date restriction for initiation of luspatercept .Patient may have received prior treatment for their disease.
• Patient must have at least 3 months of follow-up from start of luspatercept treatment at the participating site.
Exclusion Criteria:
• Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based on morphology, immunophenotype, molecular assay or karyotype
• Currently enrolled in any interventional clinical trial where the patient is being treated with an investigational product that cannot be identified.
• Idiopathic Cytopenias of Undetermined Significance (ICUS), Myelodysplastic Syndromes (MDS) patients who received or are receiving active (disease modifying) therapy for the treatment of MDS prior to the date of informed consent.
• Acute Myeloid Leukemia (AML) patients who initiated active (disease modifying treatment for AML more than 2 weeks prior to the date of consent.
• Myelofibrosis (MF) and Myelodysplastic/Myeloproliferative (MDS/MPN) overlap syndrome patients with suspected juvenile myelomonocytic leukemia (JMML). Luspatercept treated patients:
• Patient must not be currently or previously enrolled in the Connect Myeloid Registry.
• Patient must not have received luspatercept as part of a clinical trial.
Drug: Luspatercept
Primary Myelofibrosis, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
Myelodysplastic syndromes, MDS, Acute myeloid leukemia, AML, Registry, Connect®, ICUS, Idiopathic Cytopenias of Undetermined Significance, Myelofibrosis, MF, Myelodysplastic/Myeloproliferative overlap syndromes, MDS/MPN overlap syndromes
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
clinicaltrials@northshore.org
ALL
18 years and over
PHASE2
NCT02734537
Inclusion Criteria:
* PRE-REGISTRATION (STEP 0)
* Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified \[NOS\]) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (American Joint Committee on Cancer \[AJCC\] 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0
* Patient has undergone total resection of the primary tumor with curative intent
* NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery; full assay minimum turn-around time is 17-24 days
* For oropharynx primary tumors, the patient must have negative human papillomavirus (HPV) status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC)
* Patients with, per the operative and/or pathology report, positive margin(s) (tumor present at the cut or inked edge of the tumor) which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible
* A paraffin-embedded surgical tumor tissue specimen has been located is available for shipment to Foundation Medicine, Inc. following pre-registration
* NOTE: Complete the EA3132-specific FoundationOne requisition form
* Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix and/or non-melanomatous skin cancer; patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor
* Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease
* Patients with recurrent disease or multiple primaries are ineligible
* RANDOMIZATION (STEP 1)
* NOTE: Patient must meet all eligibility criteria outlined in pre-registration; patient may not be randomized until site has been notified that the central determination of p53 mutation status of the surgical tumor tissue has been completed and site has been notified of assay completion
* Per the operative report, the gross total resection of the primary tumor with curative intent was completed within 8 weeks prior to randomization
* The patient must have the following assessments done =\< 8 weeks prior to randomization:
* Examination by a head and neck surgeon
* Chest x-ray (or chest computed tomography \[CT\] scan or CT/positron emission tomography \[PET\] of the chest or magnetic resonance imaging \[MRI\]) to rule out distant metastatic disease
* Patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1 within 2 weeks prior to randomization
* Women must not be pregnant or breast-feeding; females of childbearing potential must have a blood or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and until 60 days from the last study treatment
* Absolute neutrophil count \>= 1,500/mm\^3 within 4 weeks prior to randomization
* Platelets \>= 100,000/mm\^3 within 4 weeks prior to randomization
* Total bilirubin =\< the upper limit of normal (ULN) within 4 weeks prior to randomization
* Calculated creatinine clearance must be \> 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomization
* Patient must not have an intercurrent illness likely to interfere with protocol therapy DRUG: Cisplatin, RADIATION: Intensity-Modulated Radiation Therapy, OTHER: Laboratory Biomarker Analysis
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant, Lip and Oral Cavity Squamous Cell Carcinoma, p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oral Cavity Verrucous Carcinoma, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IVA Hypopharyngeal Carcinoma AJCC v8, Stage IVA Laryngeal Cancer AJCC v8, Stage IVA Lip and Oral Cavity Cancer AJCC v8, Stage IVA Oral Cavity Verrucous Carcinoma, Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer (TAILOR RT)
clinicaltrials@northshore.org
FEMALE
35 years and over
PHASE3
NCT03488693
Inclusion Criteria:
* Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care.
* Patients must have been treated by BCS or mastectomy with clear margins of excision. Post-mastectomy positive margins for invasive disease and/or DCIS is not allowed. Multifocal disease (i.e. the presence of two or more foci or breast cancer within the same breast quadrant) and multicentric disease (i.e. the presence of two or more foci of breast cancer in different quadrants of the same breast) are allowed.
* Patients with T3N0 disease are eligible.
* Patients with disease limited to nodal micrometastases are eligible
* Patients with nodal macrometastases (\>2mm) treated by axillary dissection must have 1-3 positive axillary nodes (macrometastases, \> 2 mm).
* Patients treated by mastectomy and SLNB alone must have only 1-2 positive axillary nodes (macrometastases, \> 2 mm).
* Patients must be ER ≥ 1% and HER2 negative on local testing
* Patients must have an Oncotype DX recurrence score ≤25 obtained from testing of breast tumour tissue from a core biopsy or from the surgical specimen.
* Patient must consent to provision of, and investigator(s) must agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative marker assays described in the protocol may be conducted
* Patient must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted.
* Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Premenopausal women will receive ovarian ablation plus aromatase inhibitor therapy or tamoxifen if adjuvant chemotherapy was not administered. For all patients, endocrine therapy can be given concurrently or following RT.
* Patients may or may not have had adjuvant chemotherapy.
* RT must commence within 16 weeks of definitive surgery if the patient is not treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 12 weeks after the last dose. (Note: adjuvant chemotherapy may be ongoing at the time of randomization). Definitive surgery is defined as the last breast cancer-related surgery.
* Patient's ECOG performance status must be 0, 1 or 2.
* Patient's age must be ≥ 35 years.
* For the first 736 eligible English or French-speaking subjects who have agreed to optional questionnaire completion: Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life, health utilities and lost productivity questionnaires in either English or French (note: enrollment completed 2022Aug02)
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements
* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* In accordance with CCTG policy, protocol treatment is to begin within 6 weeks of patient randomization.
* Women of childbearing potential must have agreed to use an effective contraceptive method. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months.
Exclusion Criteria:
* Patients with nodal disease limited to isolated tumour cells (pN0i+ \< 0.2 mm).
* Patients with pT3N1 and pT4 disease (Note: patients with T3N0 are eligible).
* Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
* Synchronous or previous contralateral invasive breast cancer. (Patients with contralateral DCIS are eligible unless previously treated with radiation.)
* History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years.
* Patients who are pregnant.
* Patients that have had prior ipsilateral chestwall/thoracic radiation.
* Patients treated with chemo or endocrine therapy administered in the neoadjuvant setting for breast cancer. Endocrine therapy exposure 12 weeks or less prior to surgery is permitted.
* Patients with serious non-malignant disease (e.g. cardiovascular, scleroderma etc.) which would preclude RT.
* Patients with any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision). RADIATION: Radiation, OTHER: No Radiation
Breast Cancer
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments (PROPHETIC)
clinicaltrials@northshore.org
All
18 years and over
NCT04056247
Inclusion Criteria:
• Cancer patients with stage IV NSCLC or stage IV malignant melanoma
• Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response
• ECOG PS - 0/1-2
• Normal hematologic, renal and liver function:
• Absolute neutrophil count higher than 1500/mm3
• Platelets count higher than 100,000/mm3
• haemoglobin higher than 9 g/dL
• Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
• Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit.
Exclusion Criteria:
• Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug
• Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
Other: Plasma sample collection
Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma, Stage IV Small Cell Lung Cancer, Stage III Malignant Melanoma
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT04269902
Inclusion Criteria:
* Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration
* Participants must have CLL-International Prognostic Index (CLL-IPI) score \>= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities)
* Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. At minimum, FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
* TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p)
* Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and/or has complex cytogenetics completed
* Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration)
* Serum beta-2 microglobulin level must be obtained within 28 days prior to registration
* Participants must not meet any of the IWCLL specified criteria for active CLL therapy
* Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment
* Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
* Prior therapy with anti CD20 monoclonal antibodies is not allowed
* Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of COVID-19), or radiotherapy
* Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
* Participants must be \>= 18 years of age
* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Platelet count \>= 100,000/mm\^3 within 28 days prior to registration
* Absolute neutrophil count (ANC) \>= 1,000/mm\^3 within 28 days prior to registration
* Creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 28 days prior to registration
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN) within 28 days prior to registration
* Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration
* Participants must be able to take oral medications
* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer requiring no more than chronic hormonal therapy, or localized breast cancer requiring no more than chronic hormonal therapy
* Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor
* Participants must not have cirrhosis
* Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O.
* Active infection with hepatitis B or C:
* Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR).
* Latent infection with hepatitis B:
* Latent infection is defined as meeting all of the following criteria:
* Hepatitis B surface antigen positive
* Anti-hepatitis B total core antibody positive
* Anti-hepatitis IgM core antibody undetectable
* Hepatitis B PCR undetectable
* Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O.
* Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis
* Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the participant from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair
* Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
* Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment
* Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5, as venetoclax is extensively metabolized by CYP3A4/5
* Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
* Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification
* Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
* Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
* Participants must agree to have specimens submitted for translational medicine (MRD) as outlined
* Participants must be offered the opportunity to participate in specimen banking for future research as outlined.
* NOTE: With participant's consent, the site must follow through with specimen submission as outlined
* Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must agree to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.)
* Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, BIOLOGICAL: Obinutuzumab, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, DRUG: Venetoclax
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT04457596
Inclusion Criteria:
* HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) according to current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Central testing is not required
\* Known hormone receptor (HR) status as defined by ASCO/CAP guidelines (based on pretreatment biopsy material). Hormone receptor positive status can be determined by either known positive estrogen receptor (ER) or known positive progesterone receptor (PR) status; hormone receptor negative status must be determined by both known negative ER and known negative PR
* Patients with clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible. (Note: Patients with T1a/bN0 tumors are not eligible at initial breast cancer diagnosis are not eligible)
* Patients with residual HR-negative, HER2 positive (+) disease in the breast and/or lymph nodes per the surgical pathology report are eligible; however, patients with HR+ HER2+ cancers must have node-positive residual disease per the surgical pathology report in order to qualify for the study. The presence of residual invasive disease in the breast is not mandatory for these patients
* Patients with weakly ER-positive (1-10%) breast cancer (based on the pretreatment core biopsy) are eligible even if they have node-negative disease per the surgical pathology report
* The residual disease tissue (breast and/or lymph nodes) is not required to be HER2-positive, as eligibility for NCI-2020-03770 (A011801) is based on a positive HER2 status at the time of the initial breast cancer diagnosis
\* Note: The presence of micrometastases in lymph nodes after preoperative therapy counts as residual disease, whereas the presence of isolated tumor cells does not
* Patients with synchronous bilateral invasive disease are eligible provided both lesions were confirmed to be HER2-positive, and at least one of the lesions meets the criteria outlined above. Multifocal disease is allowed, as long as the largest biopsied breast tumor was HER2-positive
* Patients must have received neoadjuvant chemotherapy with one of the following regimens: docetaxel/trastuzumab/pertuzumab (THP), paclitaxel/methotrexate/cisplatin (TMP), doxorubicin/cyclophosphamide/paclitaxel/trastuzumab/pertuzumab (AC-TH(P)); docetaxel/carboplatin/trastuzumab/pertuzumab (TCH(P)); fluorouracil/doxorubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FAC-TH(P)), or fluorouracil/epirubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FEC-TH(P)). Note: apart from TCHP, where T is docetaxel, treatment with docetaxel or paclitaxel is acceptable
* Prior receipt of T-DM1 in the neoadjuvant setting is not allowed.
* Prior treatment must have consisted of \>= 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of \>= 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or Food and Drug Administration \[FDA\]-approved biosimilars). Patients who have received at least 9 weeks of preoperative taxane, pertuzumab and margetuximab are also eligible if they received \>= 6 cycles of systemic therapy prior to enrollment. Note: Patients who complete at least nine of a planned twelve doses of weekly paclitaxel, or three of a planned four doses of docetaxel, but discontinue prematurely due to toxicity are eligible. Patients receiving dose-dense chemotherapy regimens are also eligible. Prior use of nab-paclitaxel (Abraxane) instead of paclitaxel or docetaxel is permitted. Prior use of subcutaneous trastuzumab (Hylecta) and subcutaneous trastuzumab and pertuzumab (Phesgo) is also allowed.
* Patients who received neoadjuvant systemic therapy which included experimental HER2-targeted therapy/therapies are potentially eligible, as long as the investigational agent was not a HER2-targeted antibody-drug conjugate (e.g. T-DM1, DS-8201a \[trastuzumab deruxtecan\]) or a HER2 targeted tyrosine kinase inhibitor (TKI) (e.g. tucatinib, lapatinib, neratinib).
* Patients may have received =\< 1 cycles of T-DM1 in the adjuvant setting. Note: These patients will be randomized to receive a further 14 cycles of T-DM1 and tucatinib/placebo as tolerated. The most recent cycle of T-DM1 should have been administered =\< 5 weeks prior to registration
\* Note: Both of the following two criteria need to be met for the patient to be eligible for this study
* An interval of no more than 12 weeks between the completion date of the last definitive treatment (e.g. postoperative chemotherapy or radiation, or if neither given, breast surgical date) and the date of registration. Concurrent radiation therapy is permitted while receiving study treatment
* Patients must be registered on study within =\< 180 days of the date of the most recent definitive breast cancer surgery (not including reconstructive surgery)
* All systemic chemotherapy should have been completed preoperatively unless participating in EA1181 (CompassHER2 pathologic complete response \[pCR\]) or the BIG DECRESCENDO Trial (which is very similar to CompassHER2 pCR in terms of study design, drugs, and eligibility). However, patients who received 4 cycles of neoadjuvant THP off study can receive a further 2-4 cycles of chemotherapy postoperatively to meet eligibility for A011801. Patients who participated in EA1181 or MA41 and proceeded to surgery immediately after the de-escalated trial regimen must receive postoperative chemotherapy to complete a total of \>= 6 cycles of systemic treatment prior to enrollment on A011801, as outlined above (e.g. 4 cycles pre-operatively, and 2 cycles post-operatively). The postoperative chemotherapy regimen prescribed is at the discretion of the treating oncologist (i.e. 2-4 cycles AC or THP, other). Continuation of trastuzumab + pertuzumab (HP) pre- or post-operatively as maintenance therapy (while awaiting a surgical date or an official pathology report) is allowed for all study participants
* Toxicities related to prior systemic treatment should have resolved or be at baseline, apart from alopecia and peripheral neuropathy =\< grade 1
* Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
* Breast surgery: total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision
* For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection
* Lymph node surgery \*\* The axilla needs to be evaluated with either sentinel node biopsy or axillary lymph node dissection. If patients have a sentinel lymph node biopsy and sentinel nodes are negative, no further axillary treatment is necessary. If patients have isolated tumor cells (ITCs) in the setting of residual breast disease, at least one of the following is required: axillary lymph node dissection (ALND) or planned nodal irradiation. If patients have micro- or macro-metastatic nodal disease, ALND and planned nodal irradiation are required. Of note, co-enrollment on Alliance A011202 is not allowed
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Absolute neutrophil count (ANC) \>= 1,000/mm\^3
* Hemoglobin \>= 8 g/dL (Note: packed red blood cells \[PRBC\] transfusion is not permitted to achieve eligibility)
* Platelet count \>= 100,000/mm\^3
* Creatinine =\< 1.5 x upper limit of normal (ULN)
* Total bilirubin =\< 1.0 x upper limit of normal (ULN) or direct bilirubin within the institutional normal range for patients with Gilbert's syndrome
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
* Screening left ventricular ejection fraction (LVEF) \>= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute percentage points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be \>= 55% after completion of neoadjuvant chemotherapy. Note: LVEF assessment may be repeated once up to 3 weeks following the initial screening assessment to assess eligibility
Exclusion Criteria:
* No adjuvant treatment with any anti-cancer investigational drug within 28 days prior to registration
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum pregnancy test done =\< 7 days prior to registration is required
* Patients with known active and/or untreated hepatitis B or hepatitis C or chronic liver disease are ineligible. Patients with a diagnosis of hepatitis B or C that has been treated and cleared and normal liver function are eligible to participate in the study if the other eligibility parameters are met
* Stage IV (metastatic) breast cancer
* History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
* Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
* Evidence of recurrent disease following preoperative therapy and surgery
* Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation)
* History of exposure to the following cumulative doses of anthracyclines: doxorubicin \> 240 mg/m\^2; epirubicin or liposomal doxorubicin-hydrochloride (Myocet) \> 480 mg/m\^2. For other anthracyclines, exposure equivalent to doxorubicin \> 240 mg/m\^2
* Cardiopulmonary dysfunction as defined by any of the following:
* History of National Cancer Institute (NCI) CTCAE version (v) 5.0 grade \>= 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria class \>= II
* Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease
* High-risk uncontrolled arrhythmias: i.e., atrial tachycardia with a heart rate \> 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular block (AV)-block (second degree AV-block type 2 \[Mobitz 2\] or third degree AV-block)
* Significant symptoms (grade \>= 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy
* History of a decrease in left ventricular ejection fraction (LVEF) to \< 40% with prior trastuzumab treatment (e.g., during preoperative therapy)
* Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg)
* Current severe, uncontrolled systemic disease
* Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to registration or anticipation of the need for major surgery during the course of study treatment
* History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product
* Peripheral neuropathy of any etiology that exceeds grade 1
* Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol
* Use of a strong CYP3A4 or CYP2C8 inhibitor within 2 weeks, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to registration is prohibited.
* Please note that use of sensitive CYP3A substrates should be avoided two weeks before registration and during study treatment. Additionally, CYP3A4 or CYP2C8 inducers are prohibited as concomitant medications within 5 days following discontinuation of tucatinib treatment. Patients who require medications that are known to be sensitive substrates of CYP3A4 with a narrow therapeutic window should be excluded. BIOLOGICAL: Trastuzumab Emtansine, DRUG: Placebo Administration, DRUG: Tucatinib, OTHER: Questionnaire Administration, OTHER: Quality-of-Life Assessment
Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Invasive Breast Carcinoma, Multifocal Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Synchronous Bilateral Breast Carcinoma
Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation (BRCA-P)
clinicaltrials@northshore.org
FEMALE
25 years to 55 years old
PHASE3
NCT04711109
Inclusion Criteria:
* Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation (variant class 4 or 5)
* Age \>= 25 years and =\< 55 years at randomization
* No evidence of breast cancer by MRI or mammography (MG) and clinical breast examination within the last 6 months prior to randomization
* No clinical evidence of ovarian cancer at randomization
* Negative pregnancy test at randomization for women of childbearing potential
* No preventive breast surgery planned at time of randomization
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Written informed consent before any study-specific procedure is performed
Exclusion Criteria:
* Prior bilateral mastectomy
* History of ovarian cancer (including fallopian and peritoneal cancer)
* History of breast cancer
* History of invasive cancer except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix, stage 1 papillary or follicular thyroid cancer, atypical hyperplasia or LCIS (lobular carcinoma in situ)
* Pregnant or lactating women (within the last 2 months prior to randomization)
* Unwillingness to use highly effective contraception method during and within at least 5 months after cessation of denosumab/placebo therapy in women of childbearing potential. (Note: Women of childbearing potential should be monitored for pregnancy prior to each denosumab/placebo injection)
* Clinically relevant hypocalcemia (history and current condition), or serum calcium \< 2.0 mmol/L (\< 8.0 mg/dL)
\* Hypocalcemia defined by calcium below the normal range (a single value below the normal range does not necessarily constitute hypocalcemia, but should be 'corrected' before dosing the subject). Monitoring of calcium level in regular intervals (usually prior to investigational product \[IP\] administration) is highly recommended
* Tamoxifen, raloxifene or aromatase inhibitor use during the last 3 months prior to randomization or for a duration of more than 3 years in total (current and prior hormone replacement therapy \[HRT\] is permitted)
* Prior use of denosumab
* Subject has a known prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, or an active dental/jaw condition which requires oral surgery including tooth extraction within 3 months of enrollment
* Concurrent treatment with a bisphosphonate or an anti-angiogenic agent
* Any major medical or psychiatric condition that may prevent the subject from completing the study
* Known active infection with hepatitis B virus or hepatitis C virus
* Known infection with human immunodeficiency virus (HIV)
* Use of any other investigational product (current or prior aspirin or non-steroidal anti-inflammatory drugs \[NSAIDs\] are permitted) DRUG: Denosumab, DRUG: Placebo, OTHER: Quality-of-Life Assessment
BRCA1 Mutation, Breast Cancer, Breast Diseases, Breast Neoplasms, Breast Carcinoma, Neoplasms
RANKL, Breast Cancer Prevention, Denosumab, Bone Density Conservation Agents, Physiological Effects of Drugs
Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
clinicaltrials@northshore.org
ALL
75 years and over
PHASE2
NCT04799275
Inclusion Criteria:
* Participants must have histologically or cytologically confirmed diffuse large B-cell lymphoma (DLBCL), Ann Arbor Stage IIX (bulky), III or IV. Participants with DLBCL transformed from follicular lymphoma (FL) or marginal zone lymphoma (MZL, including mucosa-associated lymphoid tissue \[MALT\] lymphomas), lymphoplasmacytic lymphoma (LPL), or nodular lymphocyte-predominant Hodgkin Lymphoma (NLPHL) are eligible. Participants with Grade IIIB follicular lymphoma (FL) or high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements are also eligible. Participants with DLBCL that arose from prior CLL (Richter's transformation) are not eligible.
* As defined by the World Health Organization (WHO), eligible lymphoma subtypes include the following:
* DLBCL, not otherwise specified (NOS)
* DLBCL, germinal-center B-cell type (GCB)
* DLBCL, activated B-cell type (ABC)
* T-cell histiocyte-rich B-cell lymphomas (THRBCL)
* Primary cutaneous DLBCL, leg type
* Intravascular large B cell lymphoma
* EBV+ DLBCL, NOS
* DLBCL associated with chronic inflammation
* HHV8+ DLBCL, NOS
* High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
* High grade B-cell lymphoma, NOS
* Follicular lymphoma grade 3b
* Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline. Note: PET-CT will be required at end of treatment (EOT) and progression for response assessment. Participants must have measurable disease (at least one lesion with longest diameter ≥ 1.5 cm). All measurable lesions (longest diameter \>= 1.5 cm) must be assessed within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 42 days prior to registration.
* Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test (must be within 26 weeks prior to registration). Participants with known HIV must have a CD4 count checked within 28 days prior to registration, but may proceed with therapy regardless of CD4 count.
* All participants must be screened for chronic hepatitis B virus (HBV) within 28 days prior to registration. Participants with known HBV infection (positive serology) must also have a HBV viral load performed within 28 days prior to registration, and participants must have an undetectable HBV viral load on suppressive therapy within 28 days prior to registration. Participants found to be HBV carriers during screening are eligible and must receive standard of care prophylaxis. Participants with active hepatitis B (HBV viral load \> 500 IU/mL) within 28 days prior to registration are not eligible
* Participants with a known history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load within in 28 days prior to registration
* Participants must not have known lymphomatous involvement of the central nervous system (CNS)
* Participants must not have active inflammatory bowel disease (such as, Crohn's disease, ulcerative colitis), celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism, or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity
* Participants must not have a history of acute leukemia having been treated with intensive induction therapy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Participants must not have received any prior cytotoxic chemotherapy or rituximab for treatment of the newly diagnosed DLBCL except for the pre-phase treatment (within specified dose range) that may have either started before or may start after registration to S1918. Inhaled, nasal, and topical steroid use is allowed. Prior cytotoxic chemotherapy and/or antibody therapy for an indolent lymphoma prior to transformation is allowed. Up to 4 doses of intrathecal (IT) chemotherapy administered for central nervous system (CNS) prophylaxis is allowed in addition to protocol therapy. High-dose intravenous methotrexate is not allowed.
* Participants must not have received more than a cumulative of dose 250 mg/m\^2 of prior doxorubicin (or equivalent dose of another anthracycline, such as epirubicin) therapy (at any time prior to registration).
* Participants must not currently be receiving any other investigational agents
* Participant must not have a history of allergic reactions attributed to azacitidine, mannitol, or other hypomethylating agents
* Participants must be age ≥ 75
* Participants must have a Zubrod performance status of 0-2
* Participants must have adequate renal function, as demonstrated by a creatinine clearance, calculated by the Cockcroft and Gault formula, of \>= 30 ml/min that was obtained within 28 days prior to registration
* Aspartate aminotransferase (AST) =\< 2.5 x institutional upper limit of normal (IULN), alanine aminotransferase (ALT) =\< 2.5 x IULN (within 28 days prior to registration)
* Total bilirubin =\< 2 x institutional upper limit of normal (IULN), unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver (within 28 days prior to registration). Note: If total bilirubin is elevated, and direct bilirubin is subsequently performed (within 28 days prior to registration) and resulted to be =\< 2 x IULN, the participant will be considered eligible
* Absolute neutrophil count (ANC) \>= 1000/mcL (within 28 days prior to registration)
* Platelets \>= 75,000/mcL (within 28 days prior to registration)
* Hemoglobin (Hgb) \>= 8 g/ dL (within 28 days prior to registration)
* If there is a documented lymphomatous involvement of the bone marrow, bone marrow function within 28 days prior to registration, as evidenced by:
* ANC \>= 500/mcL
* Platelets \>= 50,000/mcL
* Hemoglobin (Hgb) \>= 8 g/ dL
* Participants must have a left ventricular ejection (LVEF) fraction \>= 45% as measured by echocardiogram or radionuclide (multigated acquisition scan \[MUGA\]) ventriculography within 56 days prior to registration
* For the duration of the study treatment period and for at least 4 months following the last dose of study drug, male participants must agree to use effective contraceptive methods during sexual contact with a female of childbearing potential (FCBP) and must agree to refrain from semen or sperm donation during the same timeframe. Effective contraceptive methods include a history of vasectomy, use of hormonal contraception or an intrauterine device (IUD) by the female partner, or use of condoms
* A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Participants must not have active infection (systemic fungal, bacterial, or viral infection) that is not controlled (defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
* Participants must not have active cardiac disease within 26 weeks prior to registration, including: symptomatic congestive heart failure (New York Heart Association \[NYHA\] class 4), unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or myocardial infarction
* Participants must not have \>= grade 2 neuropathy, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to registration
* Participants must not have any other known uncontrolled intercurrent illness including, but not limited to ongoing psychiatric illness/social situations that would limit compliance with study requirements
* Participants must not have a concurrent primary malignancy undergoing active therapy. Exceptions: participants may have non-melanomatous skin cancers requiring only surgical intervention. Participants may have a history of early stage breast cancer or prostate cancer in remission after surgical and/or radiation therapy on adjuvant hormonal therapy only PROCEDURE: Biospecimen Collection, DRUG: Cyclophosphamide, DRUG: Doxorubicin Hydrochloride, DRUG: Oral Azacitidine, DRUG: Prednisone, OTHER: Questionnaire Administration, BIOLOGICAL: Rituximab, DRUG: Vincristine Sulfate
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation, Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Grade 3b Follicular Lymphoma, HHV8-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements, High Grade B-Cell Lymphoma, Not Otherwise Specified, Intravascular Large B-Cell Lymphoma, Lymphoplasmacytic Lymphoma, Nodular Lymphocyte Predominant B-Cell Lymphoma, Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type, T-Cell/Histiocyte-Rich Large B-Cell Lymphoma, Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma, Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy (Astefania)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT04873362
Inclusion Criteria:
* Histologically confirmed invasive breast carcinoma
* Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer
* Centrally confirmed PD-L1 and hormone receptor status
* Clinical stage at disease presentation (prior to neoadjuvant therapy): cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible)
* Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted)
* \<=12 weeks between primary surgery and randomization
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Screening left ventricular ejection fraction (LVEF) \>= 50% and no decrease in LVEF by \>15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF \>= 55%
* Life expectancy \>= 6 months
* Adequate hematologic and end organ function
Exclusion Criteria:
* Stage IV breast cancer
* An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy
* Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors
* History of exposure to various cumulative doses of anthracyclines
* History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS)
* Current grade \>=2 peripheral neuropathy
* History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis
* History of or active autoimmune disease or immune deficiency
* Treatment with immunostimulatory or immunosuppressive agents
* Cardiopulmonary dysfunction
* Any known active liver disease DRUG: Atezolizumab, DRUG: Trastuzumab Emtansine, DRUG: Placebo, DRUG: Trastuzumab
Breast Cancer
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT04928846
Inclusion Criteria:
* Projected life expectancy of at least 12 weeks.
* Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
* Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
* If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
* A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
* A known epidermal growth factor receptor (EGFR) activating mutation status.
* Actionable alterations in genes other than EGFR .
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
* Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
* Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:
* Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase \[ALK\] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.
* Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
* Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:
* They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day \[QD\] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
Exclusion Criteria:
* Evidence of new, untreated CNS metastases.
* Evidence of leptomeningeal disease.
* Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
* Actionable epidermal growth factor receptor (EGFR) activating mutations.
* Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
* Participants who have received prior docetaxel therapy.
* A history of other malignancies except:
* Malignancy treated with curative intent and with no known active disease present for \>=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated carcinoma in situ without current evidence of disease.
* A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Unresolved or neuroendocrine histology, nor sarcomatoid features adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
* Major surgery within 21 days prior to randomization.
* Clinically significant condition(s) as listed in the protocol. BIOLOGICAL: Telisotuzumab Vedotin, DRUG: Docetaxel
Non Small Cell Lung Cancer
c-Met Overexpressing Non-Small Cell Lung Cancer, c-Met NSCLC, Telisotuzumab Vedotin, ABBV-399, Docetaxel, Cancer, Non Small Cell Lung Cancer, NSCLC, TeliMET NSCLC-01, Teliso-V
Breast Cancer Liquid Biopsy Trial
clinicaltrials@northshore.org
All
18 years and over
NCT04962529
Arm 1 Inclusion criteria:
• All subjects must be capable of providing informed consent
• Subjects (≥ 18 years of age) must have had a prior primary breast cancer diagnosis of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis. o Patients on adjuvant treatment for primary disease are eligible provided clinical progression (suspected recurrence) is evident based on radiological assessment
• Subjects must have suspected recurrent metastatic BC or MBC with clinical signs of progression that will be confirmed/evaluated by tissue biopsy that is expected to yield tissue adequate for histologic examination. Note that patients presenting with de novo metastasis are eligible provided a tissue biopsy meets the above criteria.
• Tissue biopsy of a suspected metastatic lesion must be taken prior to treatment for metastatic disease and can be either: (i) after liquid biopsy blood draw for this study, or (ii) at least one week prior to liquid biopsy blood draw for this study.
• The suspected metastases biopsied may be from any lesion outside the ipsilateral breast and axilla, infra/supraclavicular areas.
• In those with suspected metastases in contralateral axilla, infra/supraclavicular areas, only a new contralateral breast primary must be excluded by imaging.
• No history of any other cancers (except for non-melanoma skin cancer)
• Ability to access 3-month outcome data (de-identified, consented patients included for second draw at 3-month timepoint or within 14 days for the first post-treatment imaging, whichever comes first).
• Data from contemporaneous diagnosis (metastatic recurrence or de novo) and in applicable past diagnosis (primary) must be accessible, including a pathology report that details standard markers and morphology describing how malignancy/cancer of origin was determined. Arm 1
• Unable to provide informed consent
• New treatment commences prior to liquid biopsy blood collection
• Previous history of an invasive non-breast cancer (except for non-melanoma skin cancer)
• Subjects not undergoing a tissue biopsy at time of blood draw (for suspected breast cancer recurrence or prior to beginning new line of metastatic treatment)
• Subjects with only a new contralateral breast primary tumor Arm 2 Inclusion criteria:
• Capable of providing informed consent
• Subjects (≥ 18 years of age) must have had a prior primary breast cancer diagnosis of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis.
• Patients on adjuvant treatment for primary disease are eligible provided clinical progression (suspected recurrence) is evident based on radiological assessment
• The suspected metastasis biopsied may be from any lesion outside the ipsilateral breast and axilla, infra/supraclavicular areas.
• In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only, a new contralateral breast primary must be excluded by imaging.
• Confirmation of progression of MBC must be confirmed by imaging
• (Optional) Tissue biopsy of suspected metastatic lesion must be taken prior to treatment for metastatic disease and can be either: (i) after liquid biopsy blood draw for this study, or (ii) at least one week prior to liquid biopsy blood draw for this study.
• No history of any other cancers (except for non-melanoma skin cancer)
• Data from primary BCa diagnosis must be accessible, including detailed description with standard markers and morphology describing how malignancy/cancer of origin was determined.
• Subject must exhibit clinical signs of breast cancer recurrence or progression of previously confirmed metastatic breast cancer Arm 2
• Subjects unable to provide informed consent
• New treatment regimen commences prior to liquid biopsy blood collection
• Subjects on treatment for MBC with no imaging evidence of clinical progression
• Previous history of an invasive non-BC apart from cancers treated with curative intent at least five (5) years previously with no recurrence since diagnosis, with the exception of a non-melanoma skin cancer
• All subjects must be capable of providing informed consent
• Subjects (≥ 18 years of age) must have had a prior primary breast cancer diagnosis of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis. o Patients on adjuvant treatment for primary disease are eligible provided clinical progression (suspected recurrence) is evident based on radiological assessment
• Subjects must have suspected recurrent metastatic BC or MBC with clinical signs of progression that will be confirmed/evaluated by tissue biopsy that is expected to yield tissue adequate for histologic examination. Note that patients presenting with de novo metastasis are eligible provided a tissue biopsy meets the above criteria.
• Tissue biopsy of a suspected metastatic lesion must be taken prior to treatment for metastatic disease and can be either: (i) after liquid biopsy blood draw for this study, or (ii) at least one week prior to liquid biopsy blood draw for this study.
• The suspected metastases biopsied may be from any lesion outside the ipsilateral breast and axilla, infra/supraclavicular areas.
• In those with suspected metastases in contralateral axilla, infra/supraclavicular areas, only a new contralateral breast primary must be excluded by imaging.
• No history of any other cancers (except for non-melanoma skin cancer)
• Ability to access 3-month outcome data (de-identified, consented patients included for second draw at 3-month timepoint or within 14 days for the first post-treatment imaging, whichever comes first).
• Data from contemporaneous diagnosis (metastatic recurrence or de novo) and in applicable past diagnosis (primary) must be accessible, including a pathology report that details standard markers and morphology describing how malignancy/cancer of origin was determined. Arm 1
Exclusion Criteria:
• Unable to provide informed consent
• New treatment commences prior to liquid biopsy blood collection
• Previous history of an invasive non-breast cancer (except for non-melanoma skin cancer)
• Subjects not undergoing a tissue biopsy at time of blood draw (for suspected breast cancer recurrence or prior to beginning new line of metastatic treatment)
• Subjects with only a new contralateral breast primary tumor Arm 2 Inclusion criteria:
• Capable of providing informed consent
• Subjects (≥ 18 years of age) must have had a prior primary breast cancer diagnosis of any subtype at least six (6) months before presentation with suspected metastases or be presenting with de novo metastasis.
• Patients on adjuvant treatment for primary disease are eligible provided clinical progression (suspected recurrence) is evident based on radiological assessment
• The suspected metastasis biopsied may be from any lesion outside the ipsilateral breast and axilla, infra/supraclavicular areas.
• In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only, a new contralateral breast primary must be excluded by imaging.
• Confirmation of progression of MBC must be confirmed by imaging
• (Optional) Tissue biopsy of suspected metastatic lesion must be taken prior to treatment for metastatic disease and can be either: (i) after liquid biopsy blood draw for this study, or (ii) at least one week prior to liquid biopsy blood draw for this study.
• No history of any other cancers (except for non-melanoma skin cancer)
• Data from primary BCa diagnosis must be accessible, including detailed description with standard markers and morphology describing how malignancy/cancer of origin was determined.
• Subject must exhibit clinical signs of breast cancer recurrence or progression of previously confirmed metastatic breast cancer Arm 2
Exclusion Criteria:
• Subjects unable to provide informed consent
• New treatment regimen commences prior to liquid biopsy blood collection
• Subjects on treatment for MBC with no imaging evidence of clinical progression
• Previous history of an invasive non-BC apart from cancers treated with curative intent at least five (5) years previously with no recurrence since diagnosis, with the exception of a non-melanoma skin cancer
Procedure: Blood Draw
Breast Cancer, Cancer
Recurrence, Metastatic Breast Cancer, Liquid Biopsy, Protean BioDiagnostics, Blood
Pancreatic Cancer Early Detection Consortium (PRECEDE)
clinicaltrials@northshore.org
ALL
18 years to 90 years old
NCT04970056
Inclusion Criteria:
Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database:
Cohort 1
Individuals without history of PDAC meeting any of the following criteria:
• 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.
• 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
• BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
• Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
• Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
• Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+ Cohort 2 Individuals without history of PDAC meeting any of the following criteria:
• ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
• 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family
• 1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member Cohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2) Cohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort. Cohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort. Cohort 6 Individuals with a personal history of PDAC meeting any of the following criteria:
• Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
• Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
• Diagnosed ≤ age 45 Cyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)
Exclusion Criteria:
* Individuals not meeting the criteria above. Pancreas Cancer, Pancreas Cyst, Pancreatic Ductal Adenocarcinoma, Genetic Predisposition
CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer (MRD)
clinicaltrials@northshore.org
All
18 years and over
NCT05210283
Inclusion Criteria:
• Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
• Post complete surgical resection of CRC, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met:
• in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and
• histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells. i. Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension from the primary tumor must have had all or a portion of the adjacent structure removed en bloc with the primary tumor and local radiation therapy will not be utilized.
• Pathologic stage II or III
• ECOG performance status ≤ 2 (0, 1 or 2).
• Able to understand and provide written informed consent.
• Willing and able to comply with the study requirements, which includes the collection of approximately 43mL of blood for each research blood draw.
Exclusion Criteria:
• Initiated adjuvant therapy for current CRC diagnosis (note: prior neoadjuvant therapy acceptable).
• Pregnant or breastfeeding at time of enrollment.
• Prior history of any invasive cancer (including CRC) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. Patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment.
• Prior transplant history:
• Prior allogeneic hematopoietic stem cell transplant at any time.
• Prior solid organ transplant within the last 2 years prior to enrollment.
• Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.
Device: MRD
Colorectal Cancer
Colorectal, ctDNA
Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy (GenBx)
Annie Ashworth - aashworth@northshore.org
Male
40 years to 69 years old
NCT05295407
Inclusion Criteria:
• Consecutive patients undergoing prostate biopsy for detection of prostate cancer
• Aged 40 to 69 years
• Four ethnicity groups (Caucasian, African Americans, East Asians, Latinos)
• PSA between 2.5-10 ng/mL
Exclusion Criteria:
• Previous diagnosis of prostate cancer.
• Ethnicity outside the inclusion criterion (including mixed ethnicity).
• Any prior PSA test result outside the range of inclusion criterion.
Genetic: Genetic Assessment
Prostate Cancer
Prostate biopsy, prostate cancer, inherited risk assessment, PSA
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
clinicaltrials@northshore.org
ALL
40 years to 75 years old
NCT05334069
Inclusion Criteria:
* Participants with a cancer diagnosis: Documentation of disease:
* Histologic documentation: Histologically confirmed diagnosis of invasive cancer
* Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma
* For leukemia: Type (chronic lymphocytic leukemia \[CLL\], chronic myeloid leukemia \[CML\], acute lymphoblastic lymphoma \[ALL\], acute myeloid leukemia \[AML\])
* For lymphoma: Stage I-IV based on Ann Arbor staging
* For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)
* One of the following tumor types:
* Colorectal
* Bladder
* Head and neck
* Hepatobiliary
* Lung
* Lymphoma
* Leukemia
* Ovary \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
* Pancreas \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
* Multiple myeloma
* Gastric, esophageal or gastroesophageal
* Breast
* Thyroid
* Kidney
* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
* Endometrium
* Prostate
* Melanoma
\*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
* Sarcoma
* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention
* Participants with a cancer diagnosis: Age \>= 40 and =\< 75
* Participants with a cancer diagnosis: No known current pregnancy by self-report
* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis
* Participants with a cancer diagnosis: Willingness to provide blood samples for research use
* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL
* Participants with a cancer diagnosis: No history of organ transplantation
* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish
\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
* Participants without a cancer diagnosis and without suspicion of cancer: Age \>= 40 and =\< 75
* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report
* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)
* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use
* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation
* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish
\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw
\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma
* Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs
* Participants with a high suspicion of cancer: Age \>= 40 and =\< 75
* Participants with a high suspicion of cancer: No known current pregnancy by self-report
* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis
* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use
* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
* Participants with a high suspicion of cancer: No history or organ transplantation
* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages OTHER: Questionnaire Administration, PROCEDURE: Biospecimen Collection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Ann Arbor Stage I Lymphoma, Ann Arbor Stage II Lymphoma, Ann Arbor Stage III Lymphoma, Ann Arbor Stage IV Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia, Gastroesophageal Junction Adenocarcinoma, Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Invasive Breast Carcinoma, Kidney Carcinoma, Malignant Hepatobiliary Neoplasm, Malignant Solid Neoplasm, Melanoma, Muscle-Invasive Bladder Carcinoma, RISS Stage I Plasma Cell Myeloma, RISS Stage II Plasma Cell Myeloma, RISS Stage III Plasma Cell Myeloma, Sarcoma, Stage I Bladder Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage I Colorectal Cancer AJCC v6 and v7, Stage I Esophageal Cancer AJCC V7, Stage I Gastric Cancer AJCC V7, Stage I Lung Cancer AJCC v7, Stage I Ovarian Cancer AJCC v6 and v7, Stage I Pancreatic Cancer AJCC v6 and v7, Stage I Prostate Cancer AJCC v7, Stage I Uterine Corpus Cancer AJCC v7, Stage II Bladder Cancer AJCC v6 and v7, Stage II Breast Cancer AJCC v6 and v7, Stage II Colorectal Cancer AJCC v7, Stage II Esophageal Cancer AJCC v7, Stage II Gastric Cancer AJCC v7, Stage II Lung Cancer AJCC v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage II Pancreatic Cancer AJCC v6 and v7, Stage II Prostate Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7, Stage III Bladder Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage III Colorectal Cancer AJCC v7, Stage III Esophageal Cancer AJCC v7, Stage III Gastric Cancer AJCC v7, Stage III Lung Cancer AJCC v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Pancreatic Cancer AJCC v6 and v7, Stage III Prostate Cancer AJCC v7, Stage III Uterine Corpus Cancer AJCC v7, Stage IV Bladder Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Colorectal Cancer AJCC v7, Stage IV Esophageal Cancer AJCC v7, Stage IV Gastric Cancer AJCC v7, Stage IV Lung Cancer AJCC v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Pancreatic Cancer AJCC v6 and v7, Stage IV Prostate Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7, Thyroid Gland Carcinoma
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT05468489
Inclusion Criteria:
Voluntary participation in clinical studies.
Male or female aged ≥ 18 years at the time of signing the ICF.
Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
No prior systemic therapy for ES-SCLC.
At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization.
Major organs are functioning well.
Every effort should be made to provide tumor tissues for the determination of PD-L1 expression.
An ECOG PS score of 0 or 1.
An expected survival ≥ 12 weeks.
Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment.
Participant must keep contraception.
Exclusion Criteria:
Histologically or cytologically confirmed mixed SCLC.
Known history of severe allergy to any monoclonal antibody.
Known hypersensitivity to carboplatin or etoposide.
Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia.
Pregnant or breastfeeding females.
Patients with a known history of psychotropic drug abuse or drug addiction.
Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment. DRUG: Serplulimab + chemotherapy (carboplatin-etoposide), DRUG: Atezolizumab + chemotherapy (carboplatin-etoposide)
Extensive Stage Small Cell Lung Cancer
Extensive Stage Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody
Robotic vs. Open NSM for Early Stage Breast Cancer (SP NSM)
clinicaltrials@northshore.org
FEMALE
21 years and over
NA
NCT05720039
Inclusion Criteria:
* Female age 21 or older
* BMI \< 30
* Candidate for an NSM procedure with immediate reconstruction
* Diagnosis of early stage brest cancer
* Breast ptosis ≤ Grade 2.
* Cup size ≤ C.
Exclusion Criteria:
* Previous breast surgery
* Diagnosis of metastatic breast cancer
* Prior radiation treatment to the chest
* Current smokers
* Contraindication for general anesthesia or surgery.
* Known bleeding or clotting disorder.
* Pregnant or suspected to be pregnant, or actively breastfeeding DEVICE: Robotic NSM, PROCEDURE: Open NSM
Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease, Breast
robotic, NSM, Nipple sparing mastectomy, da Vinci, breast cancer, mastectomy, breast, USA, robot, SP System, Single-port
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
clinicaltrials@northshore.org
All
18 years and over
NCT05974150
Inclusion Criteria:
• All participants must be 18 years of age or older.
• Subjects may be any stage and anywhere in the treatment continuum.
• Subject participants must have a diagnosis of a breast, lung, AML, ovarian cancer or multiple myeloma.
• Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
• All participants must be able to understand English.
Exclusion Criteria:
• Any patient who cannot understand written or spoken English.
• Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
• Any patient on a treatment clinical trial.
• Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Other: Web based survey
Breast Cancer, Lung Cancer, Multiple Myeloma, Ovarian Cancer, Acute Myelogenous Leukemia
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants with High-risk Prostate Cancer Prior to Radical Prostatectomy (CLARIFY)
clinicaltrials@northshore.org
MALE
18 years and over
PHASE3
NCT06056830
Inclusion Criteria:
* At least 18 years of age.
* Signed informed consent.
* Untreated, histologically confirmed adenocarcinoma of the prostate.
* High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA \>20 ng/mL).
* Patients electing to undergo RP with PLND.
Exclusion Criteria:
* Administration of any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
* Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
* Patients with known predominant small cell or neuroendocrine PC. DRUG: 64Cu-SAR-bisPSMA
Prostate Cancer, Prostatic Neoplasms
Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
clinicaltrials@northshore.org
FEMALE
18 years and over
PHASE3
NCT06132958
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
* Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
* Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
Exclusion Criteria:
* Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas.
* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
* Has had a recurrence of endometrial carcinoma or carcinosarcoma more than 180 days after completing platinum-based therapy administered in the curative-intent or adjuvant setting without any additional platinum-based therapy received in the metastatic or recurrent setting.
* Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma. BIOLOGICAL: Sacituzumab tirumotecan, DRUG: Doxorubicin, DRUG: Paclitaxel
Endometrial Cancer
Endometrial cancer, Antibody-drug conjugate (ADC), Trophoblast cell-surface antigen 2 (TROP2)
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)
clinicaltrials@northshore.org
FEMALE
18 years to 60 years old
PHASE3
NCT05879926
Inclusion Criteria:
* A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
* The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for patients treated in the U.S., authorization permitting release of personal health information.
* Female patients must be greater than or equal to 18 years of age.
* Patients must be premenopausal (evidence of functioning ovaries) at the time of pre-entry. For study purposes, premenopausal is defined as:
* Age 50 years or under with spontaneous menses within 12 months; or
* Age greater than 50-60 years with spontaneous menses within 12 months plus follicle-stimulating hormone (FSH) and estradiol levels in the premenopausal range; or
* Patients with amenorrhea due to IUD or prior uterine ablation must have FSH and estradiol levels in the premenopausal range; or
* Patients with prior hysterectomy must have FSH and estradiol levels in the premenopausal range.
* The patient must have an ECOG performance status of less than or equal to 2 (or Karnofsky greater than or equal to 60%).
* Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
* Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
* Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.
* For patients who undergo a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS (ductal carcinoma in situ) with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. (Patients with margins positive for LCIS (lobular carcinoma in situ) are eligible without additional resection.)
* For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible if post-mastectomy RT (radiation therapy) of the chest wall will be administered.)
* Patient must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND).
* The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
* By pathologic evaluation, primary tumor must be pT1-3. (If N0, must be T1c or higher.)
* By pathologic evaluation, ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c).
* Patients with positive isolated tumor cells (ITCs) in axillary nodes will be considered N0 for eligibility purposes.
* Patients with micrometastatic nodal involvement (0.2-2 mm) will be considered N1.
* Oncotype DX RS (recurrence score) requirements\*:
* If node-negative:
* Oncotype DX RS must be RS 21-25, or
* Oncotype DX RS must be 16-20 and disease must be high clinical risk, defined as: low histologic grade with primary tumor size greater than 3 cm, intermediate histologic grade with primary tumor size greater than 2 cm, or high histologic grade with primary tumor size greater than 1 cm.
* If 1-3 nodes involved:
* Oncotype DX RS must be less than 26.
\* Patients with a "Low Risk" or "MP1" MammaPrint (a genomic test that analyzes the activity of certain genes in early-stage breast cancer) result must have eligibility assessed with an Oncotype DX RS at pre-entry (see Section 3.1). Blocks or unstained slides must be sent to the Genomic Health centralized laboratory for testing at no cost to these patients. If MammaPrint High Risk or MP2, these patients are not eligible.
* The tumor must be ER and/or PgR-positive (progesterone receptor) by current ASCO/CAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and/or PgR staining by IHC will be classified as positive.
* The tumor must be HER2-negative by current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines based on local testing results.
* The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry must be no more than 16 weeks.
* Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy. An Oncotype DX RS must be performed on core biopsy specimen obtained prior to initiation of neoadjuvant endocrine therapy if received.
* Patients with a prior or concurrent non-breast malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. This would include prior cancers treated with curative intent.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Radiation therapy should be used according to standard guidelines; the intended radiation therapy should be declared prior to pre-entry.
Exclusion Criteria:
* • Definitive clinical or radiologic evidence of metastatic disease.
* pT4 (pathological state) tumors, including inflammatory breast cancer.
* History of ipsilateral or contralateral invasive breast cancer. (Patients with synchronous and/or previous DCIS or LCIS are eligible.)
* If prior ipsilateral DCIS was treated with lumpectomy and XRT (ionizing radiation therapy), a mastectomy must have been performed for the current cancer.
* Life expectancy of less than 10 years due to co-morbid conditions in the opinion of the investigator.
Known results from most recent lab studies obtained as part of routine care prior to study entry showing ANY of the following values:
* ANC (absolute neutrophil count) less than 1200/mm3;
* Platelet count less than 100,000/mm3;
* Hemoglobin less than 10 g/dL;
* Total bilirubin greater than ULN (upper limit of normal) for the lab or greater than 1.5 x ULN for patients who have a bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin;
* AST(aspartate aminotransferase)(SGOT)/ALT (alanine transminase)(SGPT): greater than 3 × institutional ULN;
* Renal function of GFR (glomular filtration rate) less than 30 mL/min/1.73m2.
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
* Non-epithelial breast malignancies such as sarcoma or lymphoma.
* Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry. (Patients with prior ET of more than 6 weeks duration for treatment of this cancer are not eligible.) Prior tamoxifen given for breast cancer prevention is allowed. Prior AI or GnRH for fertility preservation is allowed.
* Hormonally based contraceptive measures must be discontinued prior to pre-entry (including progestin/progesterone IUDs).
* Patients with evidence of chronic hepatitis B virus (HBV) infection are ineligible unless the HBV viral load is undetectable on suppressive therapy. Patients with a history of hepatitis C virus (HCV) infection are ineligible unless they have been treated and cured or have an undetectable HCV viral load if still on active therapy.
* Pregnancy or lactation at the time of pre-entry. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry.)
* Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results. DRUG: Ovarian Function Suppression + Aromatase Inhibitor, DRUG: Adjuvant Chemotherapy + Ovarian Function Suppression
Breast Cancer
Selinexor in Maintenance Therapy After Systemic Therapy for Participants with P53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma (XPORT-EC-042)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT05611931
Inclusion Criteria:
* At least 18 years of age at the time of signing informed consent.
* Histologically confirmed EC including: endometrioid, serous, undifferentiated, and carcinosarcoma.
* TP53 wt assessed by next generation sequencing (NGS), evaluated by a central vendor.
* Completed a single line, at least 12 weeks of platinum-based therapy (not including adjuvant or neoadjuvant therapy for Stage I-III disease) and achieved confirmed partial or complete response (PR or CR) by imaging, according to RECIST version 1.1. The participants should have received treatment for:
Primary Stage IV disease, defined as:
* had a primary or later debulking surgery during first-line platinum-based therapy with R0 resection (R0 resection indicates a macroscopic complete resection of all visible tumor) and achieved CR after at least 12 weeks platinum-based therapy, OR
* had a primary or later debulking surgery during first-line platinum-based therapy with R1 resection (R1 resection indicates incomplete removal of all macroscopic disease) and achieved PR or CR after at least 12 weeks platinum-based chemotherapy, OR
* had no surgery and achieved PR or CR after at least 12 weeks platinum-based chemotherapy
OR
At first relapse (i.e., relapse after primary therapy including surgery and/or chemotherapy and/or immunotherapy for Stage I-IV disease), defined as:
* had Stage I - III disease at diagnosis and received, at initial diagnosis, adjuvant chemotherapy and relapsed later. Participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse,
* had Stage I-III disease at diagnosis and did not receive adjuvant chemotherapy at initial diagnosis and relapsed later. Participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse, OR
* had Stage IV disease at diagnosis and received initially chemotherapy with or without surgery and relapsed later. At the time of relapse, participants should have PR or CR after at least 12 weeks of platinum-based chemotherapy compared with the start of this chemotherapy at the time of relapse.
* Previous treatment with anti-programmed cell death protein 1(PD-1) or anti-programmed death-ligand 1(PD-L1) monoclonal antibody and concomitant biologic agents (e.g., bevacizumab, trastuzumab) is allowed.
* Must be able to initiate study drug 3 to 8 weeks after completion of their final dose of chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Participants must have adequate bone marrow function and organ function within 2 weeks before starting study drug as defined by the following laboratory criteria:
* Hepatic function: total bilirubin up to less than (\<) 3\*upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (\<=) 2.5\*ULN in participants without liver metastasis. For participants with known liver involvement of their tumor: AST and ALT (\<=) 5\*ULN
* Hematopoietic function within 1 week: Absolute neutrophil count (ANC) greater than or equal to (\>=) 1.5\*10\^9/liter (L); platelet count \>= 100\*10\^9/L; hemoglobin \>= 9.0 gram per deciliter (g/dL) per local laboratory results
* Renal function: estimated creatinine clearance (CrCl) of \>= 20 milliliter per minute (mL/min), calculated using the standard local formula, as applicable
• In the opinion of the Investigator, the participant must: * Have a life expectancy of at least 12 weeks, and * Be fit to receive investigational therapy * Premenopausal females of childbearing potential must have a negative pregnancy test (serum β-human chorionic gonadotropin test) prior to the first dose of study drug. Female participants of childbearing potential must agree to use highly effective methods of contraception throughout the study and for 90 days following the last dose of study drug. * Written informed consent signed in accordance with federal, local, and institutional guidelines prior to the first screening procedure.
Exclusion Criteria:
* Participants meeting any of the following exclusion criteria are not eligible to enroll in this study:
* Has any uterine sarcomas (carcinosarcomas - not excluded), clear cell or small cell carcinoma with neuroendocrine differentiation
* Received a blood or platelet transfusion during the 2 weeks prior to Cycle 1 Day 1 (C1D1). Participants' hemoglobin must be assessed within 2 weeks of screening and at least 1 week post transfusion
* Concurrent systemic steroid therapy higher than physiologic dose (\> 10 milligram per day \[mg/day\] of prednisone or equivalent). Systemic steroid therapy as pre-medication for taxane is allowed
* Insufficient time since or not recovered from procedures or anti-cancer therapy, defined as:
* Not recovered from major surgery \<= 28 days prior to Day 1 dosing. Minor procedures, such as biopsies, dental work, or placement of a port or intravenous (IV) line for infusion are permitted
* Having ongoing clinically significant anti-cancer therapy-related toxicities CTCAE Grade \> 1, with the exception of alopecia. In specific cases, participants whose toxicity has stabilized or with Grade 2 non-hematologic toxicities can be allowed following documented approval by the Sponsor's Medical Monitor
* Palliative radiotherapy within 14 days of the intended C1D1. Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect evidence of disease progression.
* Any gastrointestinal dysfunctions that could interfere with the absorption of selinexor (e.g., bowel obstruction, inability to swallow tablets, malabsorption syndrome, unresolved nausea, vomiting, diarrhea CTCAE v 5.0 \> grade 1).
* Participants unable to tolerate two forms of antiemetics for at least 2 cycles will not be eligible for the trial.
* Active, ongoing or uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of screening.
* Serious psychiatric or medical condition that could interfere with participation in the study or in the opinion of the Investigator would make study involvement unreasonably hazardous.
* Previous treatment with an XPO1 inhibitor.
* Stable disease or PD on the post-chemotherapy scan or clinical evidence of progression prior to randomization.
* Participants who received any systemic anticancer therapy including investigational agents \<= 3 weeks (or \<= 5 half-lives of the drug \[whichever is shorter\]) prior to C1D1.
* Major injuries or surgery within 14 days prior to C1D1 and/or planned major surgery during the on-treatment study period.
* Other malignant disease with disease-free \<= 3 years except: curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or ductal carcinoma in situ (DCIS) of the breast.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor, or other agents used in the study.
* Active brain metastases (e.g., stable for \< 8 weeks, no adequate previous treatment with radiotherapy and/or surgery, symptomatic, requiring treatment with anti-convulsant therapy. Corticoid therapy is allowed if administered as stable dose for at least 1 month before randomization).
* Females who are pregnant or lactating.
* Any other life-threatening illness, active medical condition, organ system dysfunction, or serious active psychiatric issue which, in the Investigator's opinion, could compromise the participant's safety or the participant's ability to remain compliant with study procedures. DRUG: Selinexor, DRUG: Matching Placebo for selinexor
Endometrial Cancer
Selinexor, KPT-330, Advanced or Recurrent Endometrial Carcinoma, XPORT-EC, ENGOT-EN20, GOG-3083, XPORT-EC-042, p53 wild-type, Tumor protein 53 wild-type
A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
clinicaltrials@northshore.org
ALL
18 years and over
PHASE3
NCT06312137
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement \[N2\]) per AJCC eighth edition guidelines.
* Has confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy.
* Is able to undergo surgery based on opinion of investigator after consultation with surgeon.
* Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy.
* Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
* Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period.
* Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization.
* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening.
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention.
Exclusion Criteria:
* Has one of the following tumor locations/types:
* NSCLC involving the superior sulcus
* Large cell neuro-endocrine cancer (LCNEC)
* Sarcomatoid tumor
* Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
* Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
* Has Grade ≥2 peripheral neuropathy.
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
* Has received prior neoadjuvant therapy for their current NSCLC diagnosis.
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.
* Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Has an active infection requiring systemic therapy.
* Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection.
* Has a severe hypersensitivity (Grade ≥3) to sacituzumab tirumotecan, any of its excipients and/or to another biologic therapy.
* Has a history of allogeneic tissue/solid organ transplant.
* Has not adequately recovered from major surgery or have ongoing surgical complications. BIOLOGICAL: Sacituzumab tirumotecan, BIOLOGICAL: Pembrolizumab, DRUG: Cisplatin, DRUG: Pemetrexed, DRUG: Gemcitabine, DRUG: Carboplatin, DRUG: Paclitaxel
Non Small Cell Lung Cancer
Carcinoma, Lung cancer, non small cell lung cancer
Precision-Based Genomics in Prostate Cancer
clinicaltrials@northshore.org
MALE
18 years and over
NCT04706663
* INCLUSION CRITERIA:
* Subjects with histologically confirmed prostate cancer.
* Must have known germline and/or somatic variants in PIK3 and/or AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, Wnt/B-catenin pathway, CDK12, and/or MMR genes: MLH1, MSH2, MSH6, PMS2, and EPCAM and/or TMB-high(\[defined as greater than or equal to 10 mutations/megabase (mut/Mb) and/or bTMB \[greater than or equal to 16 mut/Mb\]. NOTE: any platform for genomics testing is acceptable (research or CLIA-certified)
OR
* be deemed an exceptional responder. NOTE: an exceptional response is defined as achievement of either a) a complete response, or b) a confirmed partial response in a trial or treatment or a response of exceptionally long duration
* Age greater than or equal to 18 years old.
* Ability of subject to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
-None
Prostate Cancer
germline variants, somatic variants, Genetic Predisposition, Molecular Genetics, Natural History
Blue Light Cystoscopy With Cysview® Registry (BLCCR)
clinicaltrials@northshore.org
ALL
18 years and over
NCT02660645
Inclusion Criteria:
* Adult \>18 years old
* Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy
Exclusion Criteria:
* Porphyria
* Gross hematuria
* Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives DRUG: Hexaminolevulinate hydrochloride (HCL), DEVICE: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
Bladder Cancer
Cysview, Hexaminolevulinate, Hexvix, NMIBC, BLCC, Blue Light Cystoscopy with Cysview, Cystoscopy, TURBT, TUR, Fluorescent cystoscopy, Non-muscle invasive bladder cancer (NMIBC), Transurethral resection (TUR)