drugset / Trial / NCT01091168

Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer

NCT01091168

Phase 3 Completed 594 enrolled Pierre Fabre Laboratories
RandomizedParallel-groupOpen-labelTreatment

Summary

In metastatic breast cancer (MBC) patients who have already received anthracyclines, taxanes, antimetabolites and vinca-alkaloids and have developed drug resistance to these drugs, therapeutic options are very limited. Alkylating agents showed a modest activity in pretreated metastatic breast cancer. This phase III trial will compare the effectiveness and the safety profile of vinflunine to an alkylating agent of physician choice in MBC patients who have exhausted anthracyclines, taxanes, antimetabolites and vinca-alkaloids.

Timeline

Start
2009-07
Primary completion
2012-08-27
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule
Subject Cisplatin Other / unclassified
Subject Cyclophosphamide Other / unclassified
Subject Melphalan Small molecule
Subject Mitomycin C Other / unclassified
Subject Thiotepa Other / unclassified
Subject Vinflunine Small molecule 280 mg/m2 Intravenous