Search Results Within Category "Women's Health"
11results
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
Mechanistic Characterization of Uterine Pain (MCUP)
Ellen Garrisn, BS RN - pelvicpainresearch@northshore.org
Female
18 years to 45 years old
Phase 4
NCT04145518
Inclusion Criteria:
Inclusion Criteria for Primary Dysmenorrhea Group: All cases (n=70) will have pain in the
region between the umbilicus and the perineum, above the level of the inguinal ligament,
and rate their average pain greater than or equal to 6/10 (0 = no pain; 10 = worst
imaginable pain) during menses when not using NSAIDs. The investigators will use strict
inclusion criteria and verification with structural MRI to ensure patients with primary
dysmenorrhea most likely do not have endometriosis, leiomyoma, or adenomyosis as described
below. It is not possible to reliably evaluate superficial endometriosis with MRI
(Nisenblat et al., 2016), but suspicious cases for deep infiltrating endometriosis will be
confirmed by the radiologists who routinely evaluate MRIs for our gynecological surgical
service. Although it is impossible to rule out endometriosis without surgery, in select
cases The investigators will use clinical exams and criteria supported by decision trees
(Eskenazi et al., 2001; Chapron et al., 2005, 2011; Vercellini et al., 2007) that suggest
the detection of endometriosis stage 2 or higher would be unlikely (<15%) in this
population. Participants with dysmenorrhea that rate their bowel pain, dyspareunia, or
non-menstrual pelvic pain equal to or greater than 40 on 0-100 visual analog pain scale on
the McGill Pain Questionnaire will be given the option to participate in an additional
clinical exam visit. To reduce the likelihood of comorbid endometriosis, primary
dysmenorrhea participants with symptoms of endometriosis described above, will be required
to have a negative clinical exam and no immediate family history of endometriosis to
qualify for final analyses.
Inclusion Criteria for Leiomyomata Group: The investigators will also study participants
with leiomyomata (n=20) because it is a frequent cause of menstrual pain and will often be
identified in disqualified primary dysmenorrhea participants. Leiomyomata (nondegenerated)
will be diagnosed by foci homogeneously hypointense on T2, but isointense relative to
myometrium on T1 according to standard definitions (Kubik-Huch et al., 2018). To reduce
variability within this category, the investigators will restrict enrollment to small to
medium sized intramural leiomyomata (30 to 150 cm3 combined volume). The investigators
anticipate 10 participants with leiomyomata will be identified from incidental MRI during
this study, while 10 more will be recruited from advertisements and our clinic. A smaller
cohort is studied here because the main purpose of this group is to establish whether the
physiological basis for menstrual pain in women with leiomyomata is significantly different
than women with primary dysmenorrhea. Participants with leiomyomata, who are also
symptomatic with surgically diagnosed endometriosis will be excluded.
Inclusion Criteria for Endometriosis Group: Participants without leiomyomata, but
symptomatic for endometriosis (n=20) will be enrolled before planned surgical excision
(follow-up surgery from an earlier diagnosis). The investigators will confirm a diagnosis
of Stage 2, 3, or 4 endometriosis following surgery. For the patients without confirmed
abnormal surgical findings for endometriosis with dysmenorrhea will be considered as
primary dysmenorrhea cases. Dr. Tu's pelvic pain division performs over 100 laparoscopic
pain evaluations annually (many with deep infiltrating disease) enabling us to characterize
MRI signals in surgically confirmed endometriosis patients. A smaller cohort is studied
here because the main purpose of this group is to establish whether the physiological basis
for menstrual pain in women with endometriosis is significantly different than women with
primary dysmenorrhea.
Inclusion Criteria for Healthy Controls: Healthy control cases (n=20) must rate their
average menstrual pain < =2/10 over that past 6 months (without NSAID use) and have no
other concurrent pain diagnoses or leiomyomata. Their lack of concurrent pain diagnoses
will be confirmed with questionnaires (NIH PROMIS scales, Rome Foundation IBS criteria
(Palsson et al., 2016), AUA bladder pain syndrome criteria (Hanno et. al. 2012), and the
Complex Medical Symptom Inventory (Williams and Schilling, 2009) and a medical exam screen.
Healthy controls and participants with primary dysmenorrhea will be ratio-metrically
age-matched with comparable pregnancy history to ensure similar demographics between
groups.
Exclusion Criteria:
Age restrictions for all study participants: Regularly menstruating women (age 18-45) will
be identified using our well-tested community-wide recruitment strategy, including
approaching our division's busy gynecological disorders clinic, and the departments of
Ob/Gyn at NorthShore and the University of Chicago. Although women above the age of 45 can
have menstrual pain, irregularities in perimenopause could cause confounding effects on
uterine physiology and scheduling difficulty. Similarly, irregularities in menstruation,
ovulation, and pain levels in participants under age 18 could potentially detract from
meaningful interpretation of phenotypes (Seidman et al., 2018). Additionally, before age
18, the uterus is still developing and substantially increasing in size (Porcu et al.,
1989; Verguts et al., 2013). Thus, to limit potential confounding effects, participants
under the age of 18 will be investigated in a separate study.
Menstruation-related exclusion criteria for all study participants: The investigators will
exclude certain participants with conditions associated with the absence of regular menses
such as polycystic ovarian syndrome, pregnancy, current use of any continuous hormonal
medication or contraceptive, or Asherman's syndrome.
MRI-related or participation related exclusion criteria for all study participants:
The investigators will exclude participants with criteria that would affect our ability to
obtaining meaningful MRI data such as
• presence of an intrauterine device (IUD). The use of an IUD potentially affects interpretability of MRI because it creates an imaging artifact in the endometrium extending to the myometrium.
• inability to read or comprehend the informed consent written in English,
• history of metallic implants,
• history of metallic injury,
• any diagnosed condition that would preclude investigation with MRI (e.g., claustrophobia),
• BMI >40,
• allergy or inability to tolerate naproxen Exclusion criteria for known factors that affect the interpretability of the data for all study participants:
• thyroid dysfunction,
• adrenal dysfunction,
• renal disorders,
• liver disorders,
• coagulopathy,
• prolactinoma,
• von Willebrand disease,
• platelet disorders,
• diabetic neuropathy,
• gastrointestinal conditions or surgeries that would affect naproxen absorption,
• active genitourinary or sexually transmitted infection Provisional exclusion for primary analyses for all study participants: Acute or chronic conditions associated with pelvic pain with a defined anatomical cause other than endometriosis or leiomyoma (e.g., pathological ovarian cysts, significant persistent hydro/hematosalpinx, untreated pelvic inflammatory disease, active pelvic or abdominal malignancies, Mullerian anomalies, or stage 3 uterine prolapse), and comorbid diagnosis of significant leiomyoma and endometriosis. Note: these exclusion criteria may be incidentally discovered after the MRI scan and confirmed with a radiologist's or Dr. Tu's diagnosis. Provisional exclusion for adenomyosis group: Because the frequency of adenomyosis is low or unknown, and may consist of multiple subtypes resulting in heterogeneity and inadequate statistical power, adenomyosis patients are not a planned study group and diagnosed cases will be initially excluded from recruitment. Focal and diffuse adenomyosis will be excluded by guidelines (Chapron et al., 2017) adapted from the Kishi criteria (Kishi et al., 2012): maximal junctional zone thickness exceeding 12 mm, a ratio of junctional zone thickness to myometrium exceeding 40%, or high-intensity foci within the myometrium. If a substantial number of adenomyosis participants participate, as discovered after-the-fact with MRI, results will be analyzed. Intermediate levels of dysmenorrhea pain exclusion: Participants with mild menstrual pain (between 3 and 5 on a 0-10 scale) will be excluded. Our prior experience with this cohort (Westling et al., 2013) suggests that The investigators may encounter a floor effect when studying the effectiveness of NSAIDs. Also, since this cohort is most likely to respond to NSAIDs, it is imperative The investigators study the mechanisms of the most severe sufferers of refractory menstrual pain.
Drug: Naproxen Sodium
Dysmenorrhea (Disorder), Dysmenorrhea Primary, Dysmenorrhea Secondary, Endometrial Diseases, Leiomyoma, Fibroid Uterus
pain, NSAID, women's health, uterus, MRI
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
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
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
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
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
clinicaltrials@northshore.org
ALL
18 years to 75 years old
PHASE2
NCT06143956
Inclusion Criteria:
* Have a body mass index (BMI) ≥27 kg/m²
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss.
Exclusion Criteria:
* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
* Have poorly controlled hypertension.
* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
* Have any of the following cardiovascular conditions within 3 months prior to screening:
* acute myocardial infarction
* cerebrovascular accident (stroke)
* unstable angina, or
* hospitalization due to congestive heart failure.
* Have a history of symptomatic gallbladder disease within the past 2 years.
* Have a lifetime history of suicide attempts. DRUG: LY3305677, DRUG: LY3841136, DRUG: Tirzepatide, DRUG: Placebo
Obesity, Overweight
A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
clinicaltrials@northshore.org
ALL
18 years to 75 years old
PHASE2
NCT06230523
Inclusion Criteria:
W8M-MC-LAA1
* Are males and females who agree to abide by the reproductive and contraceptive requirements
W8M-MC-CWMM:
* Have a BMI ≥27 kg/m²
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)
Exclusion Criteria:
W8M-MC-LAA1
* Have any prior diagnosis of diabetes mellitus except gestational diabetes.
* Have any of the following cardiovascular conditions within 6 months prior to screening:
* acute myocardial infarction
* cerebrovascular accident (stroke)
* unstable angina, or
* hospitalization due to congestive heart failure (CHF).
* Have a history of acute or chronic pancreatitis.
* Have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline.
W8M-MC-CWMM
* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
* Have poorly controlled hypertension.
* Have a history of symptomatic gallbladder disease within the past 2 years
* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
* Have a lifetime history of suicide attempts. DRUG: LY3841136, DRUG: Placebo
Obesity, Overweight and Obesity
Overnutrition, Hormones, Chronic weight management
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