Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 2, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT02445391). This is a study registration, not published results. Lead sponsor: ECOG-ACRIN Cancer Research Group. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 415 participants (ACTUAL). Conditions: Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Triple-Negative Breast Carcinoma. Interventions: DRUG: Capecitabine; DRUG: Carboplatin; DRUG: Cisplatin. Primary outcome measures: 3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients , No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.. Brief summary: This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.