drugset / Trial / NCT02054338

A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer

NCT02054338

Phase 3 Terminated 1004 enrolled Pierre Fabre Laboratories
RandomizedParallel-groupOpen-labelTreatment

Summary

The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to paclitaxel and gemcitabine is based on the following points: the significant antitumour activity of vinflunine in metastatic breast cancer (MBC) as single agent after anthracycline-taxane exposure and recent phase I study results of the vinflunine plus gemcitabine is at least additive and both drugs have a distinct mechanism of action; since taxanes have been approved in the adjuvant setting and are widely used in the treatment of early breast cancer it is worthwhile to assess new combination chemotherapy regimens as first line therapy for metastatic breast cancer.

Timeline

Start
2006-06
Primary completion
2011-06
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2
Subject Gemcitabine Small molecule 1250 mg/m2
Comparator Paclitaxel Small molecule 175 mg/m2
Subject Vinflunine Small molecule 320 mg/m2 Intravenous