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Docetaxel in Node Positive Adjuvant Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Docetaxel in Node Positive Adjuvant Breast Cancer

A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.

NCT00688740•Sanofi

View on ClinicalTrials.gov

Summary

The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.

Detailed Description

In addition to the 5-year analysis conducted in September 2003, two other analyses were planned when 590 and 700 Disease Free Survival events occurred. However, due to the lower than predicted DFS event rate, and in agreement with FDA and EMA, a time-based final analysis at 10 years was considered more appropriate than an event-based (700 Disease Free Survival events) analysis.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

No

Inclusion Criteria

•Histologically proven breast cancer (invasive adenocarcinoma with at least one axillary lymph node showing evidence of tumor among a minimum of six resected lymph nodes).
•Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection for operable breast cancer. Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma.

Exclusion Criteria

•Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
•Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.

Locations (20)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Sanofi-Aventis Administrative Office

Vienna, Austria

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Sanofi-Aventis Administrative Office

Laval, Canada

Sanofi-Aventis Administrative Office

Prague, Czechia

Sanofi-Aventis Administrative Office

Cairo, Egypt

Sanofi-Aventis Administrative Office

Paris, France

Sanofi-Aventis Administrative Office

Berlin, Germany

Sanofi-Aventis Administrative Office

Athens, Greece

Key Dates

Start Date

June 1, 1997

Primary Completion Date

January 1, 2010

Completion Date

January 1, 2010

Last Updated

February 16, 2011

Enrollment

1,491

ACTUAL participants

Conditions

Breast Cancer

Interventions

Docetaxel

DRUG

5-fluorouracil

DRUG

Doxorubicin

DRUG

Cyclophosphamide

DRUG

Sponsors

Lead Sponsor

Sanofi

Collaborators

Cancer International Research Group (CIRG)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 16, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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