April 8, 2020 Breast Adjuvant
Clinical Trial Information
PROTOCOL: NRG-BR003
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
ELIGIBILITY:
- The trial is open to female and male patients. Age ≥ 18 years.
- ECOG Performance Status of 0 or 1.
- The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
- All of the following staging criteria must be met:
- By pathologic evaluation, primary tumor must be pT1-3
- By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c),
pN2a, pN2b, pN3a, or pN3b. - If pN0, pathological tumor must be ≥ 3.0 cm.
- The tumor must have been determined to be HER2-negative as follows.
- The tumor must have ER and PgR status assessed.
- The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy.
- 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.) - 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.)
- The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below.
- Sentinel lymphadenectomy alone:
− If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b;
− 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 must be T1 or T2 by pathologic evaluation and the nodal involvement must
be limited to 1 or 2 positive nodes. - Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or
- Axillary lymphadenectomy with or without SN isolation procedure.
- Sentinel lymphadenectomy alone:
- The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days.
- No T4 tumors including inflammatory breast cancer.
- No synchronous or previous contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
- No previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
- No 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.
- No previous therapy with anthracyclines or taxanes for any malignancy.
- No chemotherapy administered for the currently diagnosed breast cancer prior to randomization.