Phase III Trial of IV Vinflunine Versus an Alkylating Agent in Patients With Metastatic Breast Cancer Previously Treated With or Resistant to an Anthracycline, a Taxane, an Antimetabolite, and a Vinca-alkaloid (Study L00070 IN 308 B0)

NCT01091168 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Pierre Fabre Medicament
Phase	Phase 3
Status	COMPLETED
Enrolment	594
Start date	2009-07
Completion	2014-01

Conditions

• Breast Cancer
• Metastases

Interventions

• vinflunine
• Alkylating agent of physician choice registered in cancer

Primary outcomes

• Overall Survival — From baseline up to 3 years 1 month
  The main endpoint of this study is overall survival defined as the time from randomisation to the date of death or last follow-up. For patients who have not died, survival duration will be censored at the date of last contact or last follow-up or the date of last news.

Countries

Argentina, Austria, Belarus, Belgium, France, Germany, Italy, Portugal, Russia, South Africa, Spain, Taiwan, Ukraine, United Kingdom