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Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

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ClinicalTrials.gov Identifier: NCT00688740
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : February 14, 2011
Last Update Posted : February 16, 2011
Sponsor:
Collaborator:
Cancer International Research Group (CIRG)
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE May 29, 2008
First Posted Date  ICMJE June 3, 2008
Results First Submitted Date  ICMJE January 25, 2011
Results First Posted Date  ICMJE February 14, 2011
Last Update Posted Date February 16, 2011
Study Start Date  ICMJE June 1997
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2008)
Disease-free survival [ Time Frame: Study period ]
Change History Complete list of historical versions of study NCT00688740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2008)
  • Overall survival [ Time Frame: Study period ]
  • Toxicity and quality of life [ Time Frame: Study period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel in Node Positive Adjuvant Breast Cancer
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Docetaxel
    intravenous
    Other Name: Taxotere®
  • Drug: 5-fluorouracil
    intravenous
    Other Name: 5-FU
  • Drug: Doxorubicin
    intravenous
  • Drug: Cyclophosphamide
    intravenous
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Docetaxel
    • 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
    Interventions:
    • Drug: 5-fluorouracil
    • Drug: Doxorubicin
    • Drug: Cyclophosphamide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2008)
1491
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   Argentina,   Austria,   Brazil,   Canada,   Czech Republic,   Egypt,   France,   Germany,   Greece,   Hungary,   Israel,   Poland,   Portugal,   Slovakia,   South Africa,   Spain,   United Kingdom,   United States,   Uruguay
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00688740
Other Study ID Numbers  ICMJE EFC6041
XRP6976D-316
BCIRG001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, Sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Cancer International Research Group (CIRG)
Investigators  ICMJE
Study Director: ICD Sanofi
PRS Account Sanofi
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP