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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
Genders 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.
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Please refer to this study by its identifier: NCT00688740

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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  XRP6976D-316  BCIRG001 
Study First Received: May 29, 2008
Results First Received: January 25, 2011
Last Updated: February 14, 2011
Health Authority: Poland: Ministry of Health
Canada: Health Canada
Spain: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Sanofi:
adjuvant treatment

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators processed this record on May 26, 2016