Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

Status: Recruiting
Phase: Phase 3
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01272037 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-359


This phase III clinical trial is studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy works in treating patients with invasive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer


Conducting Institutions:
Brigham and Women's Hospital, Dana Farber Cancer Institute at Milford, Dana-Farber Cancer Institute, Dana Farber Cancer Institute at Faulkner Hospital, Massachusetts General Hospital/ North Shore Cancer Center, Beth-Israel Deaconess Medical Center

Overall PI:
Nancy Lin, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Erica Mayer, MD, Dana-Farber Cancer Institute
Michael Constantine, M.D., Dana Farber Cancer Institute at Milford Hosptial
Karen Krag, MD, Massachusetts General Hospital
Christina Herold, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Histologically confirmed invasive breast cancer meeting the following criteria: - 1-3 node-positive disease (pN1mi, pN1a, pN1b, or pN1c) by sentinel node biopsy or axillary lymph node dissection - Positive estrogen receptor (ER) and/or progesterone receptor (PR) status according to American Society of Clinical Research/College of American Pathologists (ASCO/CAP) guidelines - Considered positive if >= 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal [normal epithelial elements] and external controls - Negative HER-2 as determined by IHC or non-amplified fluorescence in situ hybridization (FISH) for screening - If HER2 is 2+ by IHC, FISH must be performed and must not be positive (must be a ratio of =< 2.2) - If IHC is 0 or 1+ by institutional standards, FISH is not required - Patients with FISH in the indeterminate range (a ratio of 1.8 to 2.2) allowed provided they are not planning to receive treatment with trastuzumab - Recurrence Score (RS) by Oncotype DX =< 25 - Submission of tissue (paraffin block from primary tumor, positive and negative lymph node block) from surgery required - Prior diagnosis of DCIS allowed provided it was treated with mastectomy alone (no therapeutic radiation or endocrine therapy) - No inflammatory breast cancer or metastatic disease - Must have had breast-conserving surgery with planned radiotherapy or total mastectomy (with or without planned post mastectomy radiation) with clear margins within the past 28-84 days - Menopausal status: pre- or post-menopausal - Zubrod performance status 0-2 - Not pregnant or nursing - Fertile patients must use an effective non-hormonal contraception method while on treatment and for ≥ 3 months after completion of protocol treatment - No other prior malignancy except adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage 0, I, or II cancer from which the patient is currently in complete remission; or any other cancer from which the patient has been disease-free for the past 5 years - LVEF ≥ 50% if an anthracycline-based regimen is planned - Patients randomized to chemotherapy may also co-enroll in Phase III trials that compare chemotherapies - No prior chemotherapy or endocrine therapy for breast cancer - No prior preventive tamoxifen or raloxifene - No prior therapeutic breast radiotherapy - Not requiring concurrent chronic treatment with systemic steroids or other immunosuppressive agents - Patients randomized to either arm may also co-enroll in Phase III trials that compare local therapies or compare systemic therapies (not including chemotherapy)
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