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

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COMPLETEDPhase 3NCT00688740

Docetaxel in Node Positive Adjuvant Breast Cancer

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...

Lead sponsor: Sanofi•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Sanofi

Collaborators

Cancer International Research Group (CIRG)

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.

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 16, 2011Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment1,491

Start dateJun 1997

Last updatedFeb 16, 2011

Condition

Locations shown

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey

Sanofi-Aventis Administrative Office

Buenos Aires

Sanofi-Aventis Administrative Office

Vienna

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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: June 28, 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.

View ClinicalTrials.gov Terms and Conditions