6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer

NCT00189644 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2005-09-19

No results posted yet for this study

Summary

The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.

Conditions

Interventions

PROCEDURE

6 FEC 100

PROCEDURE

4 FEC 100 followed by 4 Taxol

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY
  • Association Européenne de Recherche en Oncologie

    lead OTHER

Principal Investigators

  • Pascal Piedbois, MD · Association Europeenne de Recherche en Oncologie

  • Anne-Chantal Braud, MD · Association Europeenne de Recherche en Oncologie

  • Daniel Serin, MD · Association Europeenne de Recherche en Oncologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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Entities

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 NCT00189644 on ClinicalTrials.gov