Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer

Development of an active second‐line treatment option for metastatic breast cancer patients previously pre‐treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings. For each randomisation arm, 100 patients will be included. The trial was performed as a 2‐stage phase II study according to the optimal design by Simon with overall response rate as the primary objective. Study Design: Arm A: Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1 q 3 weeks; Arm B: Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1 q 3 weeks;