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Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer

NCT01091168 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 594

Last updated 2019-09-16

Study results available
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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.

Conditions

Interventions

DRUG

vinflunine

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

DRUG

Alkylating agent of physician choice registered in cancer

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

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Karim Keddad, MD, PhD · Institut de Recherche Pierre Fabre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-08-27
Completion
2014-01-31

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01091168 on ClinicalTrials.gov