Study ID: EA1131
A randomized phase 3 post-operative trial of platinum-based chemotherapy vs. capecitabine in patients with residual triple-negative breast cancer
This treatment trial is for patients who have been diagnosed with residual triple-negative stage 2 or 3 breast cancer and have had surgical resection of the primary tumor, a mastectomy or lumpectomy. Patients are randomized into two study arms. One group receives cisplatin and carboplatin, which are platinum-based chemotherapies administered intravenously. The other group receives the oral anti-cancer medication capecitabine.
- Diagnosis: Histologically confirmed triple negative (ER-/ PR-/HER2-) invasive stage II-III.
- Neoadjuvant taxane +/- anthracycline must be complete; no cisplatin or carboplatin as part of the neoadjuvant therapy regimen.
- Must have complete definitive resection of primary tumor. Mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable. Sentinel node biopsy post neoadjuvant chemotherapy (i.e., at the time of definitive surgery) is allowed; axillary dissection encouraged with lymph node involvement, but not mandatory.
- Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery; residual cancer is defined as a contiguous focus of residual invasive cancer in the breast measuring >= 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination.
Notes: Doses based on actual body weight; Calvert Formula is used for carboplatin dosing; choice of platinum agent will be per treating physician. Once a platinum agent is picked, no changes allowed.
All patients will be followed for development of recurrences, second primary cancer and survival based on standard ECOG-ACRIN following schedules.
Arm A: Observation CLOSED
Arm B: Cisplatin or Carboplatin: Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm C: Capecitabine: Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- Must have been diagnosed with residual triple-negative invasive stage 2 or 3 breast cancer
- Must have already undergone surgical resection, mastectomy or lumpectomy