The links after "Participants" show which Southwest Oncology Group 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.

Disease Committee: Breast Cancer

Participants: Members, CCOP, Affiliates, Medical Oncologists, Pathologists, CTSU

Eligibility Criteria: Histologically confirmed diagnosis of operable Stage I, II, or III invasive breast carcinoma with known estrogen or progesterone receptor status;

Patients with T4 tumors are not eligible;

Patients with bilateral synchronous breast cancer diagnosed within 1 month of each other are eligible;

Patients must be high risk by meeting one of the following criteria:
(1) tumor >/= 2 cm in greatest diameter (includes both invasive & intraductal component;
(2) tumor >/= 1 cm in diater and either ER-/PgR- OR ER+ or PgR+ with a Genomic Health Recurrence Score of >/= 26;
(3) one of more axillary or intramammary nodes are positive;

Either modified radical mastectomy or local excision of all tumors plus an axillary lymph node dissection or sentinel node resection prior to registration;

Patients must have at least 6 axillary or intramammary lymph nodes sampled, with the exception of patients who have a sentinel node procedure with all sampled nodes being uninvolved by malignancy;

Patients must be registered within 84 days from final surgical procedure;

No prior cytotoxic chemotherapy or chemotherapy with anthracycline, anthrcenedione, or taxane;

Co-enrollment in S0230, NSABP B-39, IBCSG 24-02 (SOFT), and IBCSG 25-02 (TEXT) are allowed;

No prior radiation therapy except for partial breast irradiation (PBI);

PBI must be completed at least 2 wks prior to registration;

RT for prior DCIS ok if done 2 wks before registration;

No clinical diagnosis for congestive heart failure or angina pectoris;

If history of hypertension or age >=60 years, MUGA, echocardiogram scan, or cardiac catheterization must be performed within 42 days prior to registration and LVEF %>= ILLN;

Serum creatinine and bilirubin <= IULN; alkaline phosphatase <= 2x IULN; SGOT/SGPT <= 2x IULN; ANC >= 1, 2000; platelet count >= 100,000;

No nursing or pregnant women;

No other prior malignancy is allowed except for the following: adequately trated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma in-situ or the breast (LCIS), or any other cancer from which the patient has been disease-free fro 5 years. Patients with prior invasive breast cancer or ductal carcinoma in-situ (DCIS) are eligible if they have been disease free for 5 years;

Age 18 or greater;

PS 0-2;

No known HIV;

For patients who consent to the genetic polymorphism sample submission, a pretreatment sample of 17 mL of blood (10 mL for banking and 7 mL for DNA extractions) must be submitted.

Women with HER2+ tumors may have trastuzumab added to their S0221 treatment.