The links after "Participants" show which SWOG institutions are eligible to participate in this study.
The orange "Where is This Study Open?" tab at the bottom of the page shows the institutions whose Institutional Review Boards (IRBs) have approved the protocol so that it can be opened at that institution. Clicking on the Institution Name will show the points of contact for information about this study at that institution.
- Phase III Intergroup
Status Notes: Step 1 Registration will be closed to accrual effective October 1, 2015 and Step 2 Registration will be closed to accrual effective October 15, 2015.
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
Study Coordinator(s): Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D.
Participants:Members, NCORP, Affiliates, Medical Oncologists, CTSU
Eligibility Criteria: -Pts must have histologically confirmed node + (1-3 nodes) invasive breast carcinoma with + estrogen and/or progesterone receptor status, and be HER2 neg, by IHC or gene amplification evaluation (e.g., FISH/CISH/etc.). If HER2 IHC is 2+, an evaluation for gene amplification must be performed and must not be amplified. -Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed. -Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant. -Multicentric disease is defined as more than one invasive cancer >/= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants. -Synchronous bilateral disease is defined as invasive breast cancer with + lymph nodes in at least one breast, diagnosed within 30 days of each other. -Pts will have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection. Pts must have at least one, but no more than three known + lymph nodes. -Pts must not have inflammatory breast cancer and must not have metastatic disease. Pts with prior DCIS diagnosis are eligible if they received mastectomy alone. Pts must have had either breast-conserving surgery with planned radiation or total mastectomy and must have clear margins. -Pts must have had either breast-conserving surgery w/planned radiation or mastectomy and have clear margins. -Reg of patients who have not had had Ocotype DX screening must be no later than 56 days after surgery. If not performed, pts must submit tissue samples for testing to determine Recurrence Score value. If score is known and </= 25, pts must be registered to Step 2 immediate after Step 1 reg. if > 25, pt is ineligible. -Pts must be female >/= 18 yrs of age. -Pts must have PS 0-2. -Pts must be able to receive Taxane and/or anthracycline based chemo. -Pts must not have begun chemo or endocrine therapy for breast cancer. -Pts must not require chronic systemic steroid or other immunosuppressants. -Pts must not have received preventive tamoxifen or raloxifene, or have prior therapeutic ipsilateral breast radiation, unless it’s partial breast irradiation for index tumor. -Pts must not be pregnant or nursing. -No prior malignancy is allowed except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 0-2 cancer from which the pt is in CR or any other cancer from which the pt has been disease free for 5 yrs. -Pts must be offered QOL Economic Substudy.(if able to complete English questionnaire).