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).
Eligibility Criteria Expand/Collapse
-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 itï¿½s 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).
Publication Information Expand/Collapse
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