Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer
Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
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;