Spots Global Cancer Trial Database for Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

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Trial Identification

Brief Title: Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

Official Title: Randomized Phase III Trial Comparing Vinorelbine vs. Gemcitabine Plus Vinorelbine in Patients With Advanced Breast Cancer, Previously Treated With Anthracyclines and Taxanes

Study ID: NCT00128310

Conditions

Breast Cancer

Neoplasm Metastasis

Interventions

Vinorelbine

Gemcitabine

Study Description

Brief Summary: This is a multicenter, randomized, prospective, Phase III study in which patients with advanced breast carcinoma previously treated with anthracyclines and taxanes will be randomly assigned to receive one of two treatment options: vinorelbine (Arm A) or gemcitabine plus vinorelbine (Arm B).

Detailed Description: The investigators assume that progression-free survival mean time for patients treated with vinorelbine will be 3 months, and for patients treated with gemcitabine plus vinorelbine will be 5 months. That implies a reduction in risk ratio of 40% (Hazard ratio = 1,67). Assuming a bilateral alpha error of 0.05 and beta error of 10%, and the number of events needed if 60% of patients have progressed after 1 year, the number of patients needed per treatment arm is 114. Considering a 10% post-randomization drop-out, the final number of patients is 252 (126 per arm).