CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 594 enrolled
Drug / intervention
vinflunine +1 moredrug
Likely dose
vinflunine 280 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01091168
NCT01091168Phase 3Completed
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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)

Pierre Fabre Medicament·interventional·Posted Mar 23, 2010·Updated Sep 16, 2019

In Brief

A Phase 3 clinical trial evaluating vinflunine and Alkylating agent of physician choice registered in cancer for Breast Cancer and Metastases. Completed, enrolled 594 participants across 80 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Metastases
CountriesArgentina, Austria, Belarus, Belgium, France, Germany, Italy, Portugal, Russia, South Africa, Spain, Taiwan, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2010
Enrollment StartJul 1, 2009
Primary CompletionAug 27, 2012
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 16.3 years ago

Interventions

vinfluninedrug

280 mg/m2 on day 1 of each cycle every 3 weeks

Alkylating agent of physician choice registered in cancerdrug

cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin