Spots Global Cancer Trial Database for Docetaxel in Node Positive Adjuvant Breast Cancer
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Trial Identification
Brief Title: Docetaxel in Node Positive Adjuvant Breast Cancer
Official Title: 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.
Study ID: NCT00688740
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office, Buenos Aires, , Argentina
Sanofi-Aventis Administrative Office, Wien, , Austria
Sanofi-Aventis Administrative Office, Sao Paulo, , Brazil
Sanofi-Aventis Administrative Office, Laval, , Canada
Sanofi-Aventis Administrative Office, Praha, , Czech Republic
Sanofi-Aventis Administrative Office, Cairo, , Egypt
Sanofi-Aventis Administrative Office, Paris, , France
Sanofi-Aventis Administrative Office, Berlin, , Germany
Sanofi-Aventis Administrative Office, Athens, , Greece
Sanofi-Aventis Administrative Office, Budapest, , Hungary
sanofi-aventis Administrative office, Natanya, , Israel
Sanofi-Aventis Administrative Office, Warszawa, , Poland
Sanofi-Aventis Administrative Office, Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office, Bratislava, , Slovakia
Sanofi-Aventis Administrative Office, Midrand, , South Africa
Sanofi-Aventis Administrative Office, Barcelona, , Spain
Sanofi-Aventis Administrative Office, Bromma, , Sweden
Sanofi-aventis adminsitrative office, Guildford Surrey, , United Kingdom
Sanofi-aventis administrative office, Montevideo, , Uruguay
Contact Details
Name: ICD
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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