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A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer

NCT02054338 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1004

Last updated 2019-08-28

Study results available
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Summary

The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to paclitaxel and gemcitabine is based on the following points: the significant antitumour activity of vinflunine in metastatic breast cancer (MBC) as single agent after anthracycline-taxane exposure and recent phase I study results of the vinflunine plus gemcitabine is at least additive and both drugs have a distinct mechanism of action; since taxanes have been approved in the adjuvant setting and are widely used in the treatment of early breast cancer it is worthwhile to assess new combination chemotherapy regimens as first line therapy for metastatic breast cancer.

Conditions

Interventions

DRUG

Vinflunine+Gemcitabine

Vinflunine 320 mg/m² IV on day 1 and.Gemcitabine 1000 mg/m² on days 1 and 8 of each cycle repeated every 3 weeks

DRUG

Paclitaxel+Gemcitabine

paclitaxel 175 mg/m² on day 1 plus gemcitabine 1250 mg/m² on days 1

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Karim Keddad, MD, PhD · Employed Pierre Fabre Medicament

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
2006-06-30
Primary Completion
2011-06-30
Completion
2015-02-28

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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 NCT02054338 on ClinicalTrials.gov