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Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer

NCT01095003 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 770

Last updated 2022-04-28

Study results available
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Summary

The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant.

Conditions

Interventions

DRUG

Vinflunine plus Capecitabine

Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

DRUG

Capecitabine

Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Jean-Claude VEDOVATO · Pierre Fabre Medicament

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-12-31
Completion
2015-10-31

Countries

  • Argentina
  • Belarus
  • Belgium
  • Brazil
  • Bulgaria
  • Czechia
  • Estonia
  • France
  • Hungary
  • India
  • Italy
  • Mexico
  • Poland
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT01095003 on ClinicalTrials.gov