Phase II Study of Carboplatin, Vinorelbine and Capecitabine in Patients with Metastatic Breast Cancer

Most patients with breast cancer receive anthracyclines and taxanes in either the adjuvant or metastatic setting. Carboplatin, vinorelbine and capecitabine each has single agent activity in breast cancer. In addition they are non-cross resistant and generally have non-overlapping toxicities. The purpose of this study is to assess the response rate of this triplet combination in women with metastatic breast cancer previously treated with anthracycline and taxane based chemotherapy. The dosing schedule was carboplatin 300mg/m2 day 1, vinorelbine 25mg/m2 day 1 & 8 and capecitabine 1500mg/m2/day on days 1-14 every 21 days. Twenty three patients were evaluable for both efficacy and toxicities. Seventy eight percent of patients had refractory disease. The overall response rate was 65%. Complete responses were observed in 13%, and partial responses in 52%. The median progression free survival was 5.5 months. The Kaplan-Meier estimated median survival was 17.5 months. Two patients (8%) progressed on chemotherapy and 43% of patients received additional systemic therapy following participation in this study. Grade 3-4 neutropenia, anemia, and thrombocytopenia occurred in 30%, 7% and 5% of 128 cycles, respectively. Thirty seven percent of cycles required G-CSF support. One patient died of respiratory failure, possibly related to treatment. The regimen of carboplatin, vinorelbine and capecitabine has significant activity in this refractory heavily pretreated population, making it a promising therapeutic option in women with metastatic breast cancer.