PROTOCOL: NRG-BR003

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department at (810)762-8181, (810)762-8079 or (810)762-8038 to discuss full eligibility requirements.

ELIGIBILITY:

SCHEMA  NRG-BR003

1. The trial is open to male and female, but they must be at least 18 years of age.
2. ECOG Performance Status 0-1.
3. The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
4. All of the following staging criteria must be met: 1. By pathologic evaluation, primary tumor must be pT 1-3;  2. By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3, or pN3b.  3. If pN0, pathological tumor must be equal or greater to 3.0cm.
5. The tumor must have determined to be HER-2 negative as follows: 1. Immunohistochemistry (IHC) 0-1+ or 2. IHC 2+ and ISH non-amplified with a ratio or HER-2 to CEP17 < 2.0 and if reported, average HER-2 gene copy number < 4 signals/cells; or 3. ISH non-amplified with a ratio of HER-2 to CEP17 < 2.0 and if reported, average HER-2 gene copy number < 4 signals/cells.
6. The tumor must have ER and PgR status assessed using current  ASCO/CAP Guidelines. Patients are eligible if the tumor staining meets one of the following criteria: 1. ER-negative and PgR-negative by ASCO/CAP guidelines, or  2. ER or PgR stains are positive in 1-9% of cells and neither is positive in > or equal to 10% of cells.
7. The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparring) or lumpectomy.
8. For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist.  If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins.  If tumor is still present at the resected margin after re-excision(s), the patient must undergo mastectomy to be eligible.  (Patients with margins positive for LCIS are eligible without additional resection).
9. For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible as long as post-mastectomy RT of the chest wall will be administered)
10. The patient must have completed one of the procedures for evaluation of pathologic nodal status listed: 1.  Sentinel lymphadenectomy alone: a. If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b;  b. If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a and the patient has undergone breast conserving surgery (with planned breast radiotherapy), the primary tumor be T1 or T2 by pathologic evaluation and the nodal involvement must be limited to 1 or 2 positive nodes.  2. Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or  3. Axillary lymphadenectomy with or without SN isolation procedure.
11. The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days.

INELIGIBILITY:

1. T4 tumors including inflammatory breast cancer.
2. Definitive clinical or radiologic evidence of metastatic disease.  Required imaging studies must have been performed within 90 days prior to randomization.
3. Synchronous or previous contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible).
4. Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible).
5. History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.
6. Use of any investigational product within 4 weeks prior to randomization.