NRG-BR003 - "A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer"
Breast, female or male, triple neg, node pos or high risk node neg, invasive; adj doxorubicin+cyclophosphamide followed by paclitaxel w/w out carboplatin
Brief Eligibility Overview
PLEASE CONTACT NCORP - KC (913/948-5588) WITH ANY STUDY QUESTIONS.
- The trial is open to female and male patients.
- Age ≥ 18 years.
- ECOG Performance Status of 0 or 1
- All of the following staging criteria (according to the 7th edition of the AJCC Cancer Staging Manual) 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, tumor must be > 3.0 cm.
- The tumor must have been determined to be HER2-negative as follows:
- Immunohistochemistry (IHC) 0-1+; or
- IHC 2+ and ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells; or
- ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells.
- The tumor must have been determined to be ER-and PgR-negative assessed by current ASCO/CAP Guidelines. Patients with < 1% ER and PgR staining by IHC are considered negative.
- 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.
- The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days.