Vanderbilt-Ingram Cancer Center

The purpose of this study is to find out if the Oncotype DX- Recurrence Score can help decide whether patients should receive chemotherapy or not. This study is being done in patients with lower Recurrence Scores (25 or less). Currently most women who have the kind of breast cancer you have are treated with endocrine therapy (treatment that works with hormones). Many women also receive chemotherapy. No one really knows which patients with lower Recurrence Scores need to get chemotherapy. Some women may be getting chemotherapy who do not need it. These women may be exposed to side effects of their treatment that are not a necessary risk in relation to the benefit they receive. If the results of the study show that the benefit for getting chemotherapy is dependent on the Recurrence Score, the study should be able to identify a Recurrence Score level where chemotherapy should be considered (and a recurrence score level where chemotherapy may not be needed).

Criteria
 Inclusion Criteria:

 • Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2, as determined by IHC or gene amplification evaluation (e.g. FISH, CISH, etc.); estrogen and progesterone receptor positivity must be assessed according to ASCO/CAP guidelines as either ER or PR >= 1% positive nuclear staining; if HER2 IHC is 2+, an evaluation for gene amplification must be performed and must not be amplified, but otherwise gene amplification evaluation is not required if IHC is 0 or 1+ by institutional standards

 • Patients must not have inflammatory breast cancer and must not have metastatic disease; patients with a prior diagnosis of DCIS are eligible if they received mastectomy alone (no therapeutic radiation, intraoperative radiation, or endocrine therapy); radiation in the opposite breast is acceptable

 • 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)

 • 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; (NOTE: The Oncotype DX testing must be completed on the largest lesion)

 • 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; (NOTE: Oncotype DX testing should be completed on all tumors and the determination for eligibility should be made on the highest recurrence score)

 • Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other; (NOTE: The Oncotype DX testing should be completed on both tumors and the tumor with the highest recurrence score should be used)

 • Patients must be able to receive taxane and/or anthracycline based chemotherapy

 • The Quality of Life and Economic Substudy is permanently closed to accrual effective 12/1/12; patients who are able to complete a questionnaire in English must be offered the opportunity to participate in the Quality of Life and Economic Substudy. (The Quality of Life and Economic Substudy is available to U.S. INSTITUTIONS ONLY); patients who are not able to complete a questionnaire in English are registered to S1007 without participating in the Quality of Life and Economic Substudy

 • Patients who consent to participate in the Quality of Life and Economic Substudy and who do not yet know the results of their Oncotype DX screening must agree to complete the S1007 Health-Related Quality of Life Questionnaire: Enrollment between 14 days prior to and 7 days after Step 1 Registration

 • Patients who consent to participate in the Quality of Life and Economic Substudy and who do already know their Oncotype DX Recurrence Score (and it is 25 or less) will proceed to Step 2 Registration without completing the S1007 Health-Related Quality of Life Questionnaire Enrollment Form (but will complete the S1007 Health-Related Quality of Life Questionnaire: Randomized Study Form)

 • Patients or their legally authorized representative 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; for Step 1 registration of patients who have not yet submitted specimens for the Oncotype DX Breast Cancer Assay, the appropriate consent form is the Step 1 Consent Form; for both Step 1 and Step 2 registration of patients whose Recurrence Score is already known and is 25 or less, the appropriate consent form is the Step 2 Consent Form