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Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

This study has been completed.
Cancer International Research Group (CIRG)
Information provided by:
Sanofi Identifier:
First received: May 29, 2008
Last updated: February 14, 2011
Last verified: February 2011
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.

Condition Intervention Phase
Breast Cancer Drug: Docetaxel Drug: 5-fluorouracil Drug: Doxorubicin Drug: Cyclophosphamide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants With Disease-Free Survival Events [ Time Frame: up to 10 year follow-up ]
    Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.

Secondary Outcome Measures:
  • Number of Participants With Overall Survival Events [ Time Frame: up to 10 year follow-up ]
    Overall Survival - time from the date of randomization up to the date of death of any cause.

  • Number of Participants With Second Primary Malignancies (Toxicity) [ Time Frame: up to 10 year follow-up ]
    Toxicity (second primary malignancies)- defined as histopathologically proven cancer, excluding nonmelanomatous skin cancer, in situ carcinoma of the cervix, and in situ carcinoma of the breast.

Enrollment: 1491
Study Start Date: June 1997
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAC (Docetaxel)
docetaxel (75 mg/m^2) in combination with doxorubicin (50 mg/m^2) and cyclophosphamide (500 mg/m^2) on day 1 every 3 weeks for 6 cycles of treatment
Drug: Docetaxel
Other Name: Taxotere®
Drug: Doxorubicin
Drug: Cyclophosphamide
Active Comparator: FAC (5-fluorouracil)
5-fluorouracil (500 mg/m^2) in combination with doxorubicin (50 mg/m^2) and cyclophosphamide (500 mg/m^2) on day 1 every 3 weeks for 6 cycles of treatment
Drug: 5-fluorouracil
Other Name: 5-FU
Drug: Doxorubicin
Drug: Cyclophosphamide

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00688740

  Hide Study Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
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
Czech Republic
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
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Bromma, Sweden
United Kingdom
Sanofi-aventis adminsitrative office
Guildford Surrey, United Kingdom
Sanofi-aventis administrative office
Montevideo, Uruguay
Sponsors and Collaborators
Cancer International Research Group (CIRG)
Study Director: ICD Sanofi
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ICD Study Director, Sanofi-aventis Identifier: NCT00688740     History of Changes
Other Study ID Numbers: EFC6041
Study First Received: May 29, 2008
Results First Received: January 25, 2011
Last Updated: February 14, 2011

Keywords provided by Sanofi:
adjuvant treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites, Antineoplastic processed this record on September 21, 2017