Metastatic Breast Cancer Clinical Trial
Official title:
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Carboplatin Versus Gemcitabine Plus Carboplatin
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;
n/a
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