Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

This study has been completed.
Sponsor:
Collaborator:
Cancer International Research Group
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00688740
First received: May 29, 2008
Last updated: February 14, 2011
Last verified: February 2011

May 29, 2008
February 14, 2011
June 1997
January 2010   (final data collection date for primary outcome measure)
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.
Disease-free survival [ Time Frame: Study period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00688740 on ClinicalTrials.gov Archive Site
  • 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.
  • Overall survival [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Toxicity and quality of life [ Time Frame: Study period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Docetaxel in Node Positive Adjuvant Breast Cancer
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.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Docetaxel
    intravenous
    Other Name: Taxotere®
  • Drug: 5-fluorouracil
    intravenous
    Other Name: 5-FU
  • Drug: Doxorubicin
    intravenous
  • Drug: Cyclophosphamide
    intravenous
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1491
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Austria,   Brazil,   Canada,   Czech Republic,   Egypt,   France,   Germany,   Greece,   Hungary,   Israel,   Poland,   Portugal,   Slovakia,   South Africa,   Spain,   Sweden,   United Kingdom,   Uruguay
 
NCT00688740
EFC6041, XRP6976D-316, BCIRG001
Yes
ICD Study Director, Sanofi-aventis
Sanofi
Cancer International Research Group
Study Director: ICD Sanofi
Sanofi
February 2011

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