Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)

• 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: Sanofi
• Collaborator: Cancer International Research Group (CIRG)
• Information provided by: Sanofi

Tracking Information

• First Submitted Date: May 29, 2008
• First Posted Date: June 3, 2008
• Results First Submitted Date: January 25, 2011
• Results First Posted Date: February 14, 2011
• Last Update Posted Date: February 16, 2011
• Study Start Date: June 1997
• Actual Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: May 29, 2008): Disease-free survival [ Time Frame: Study period ]

Current Secondary Outcome Measures (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 (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: 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.
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Cancer

Intervention

• Drug: Docetaxel
  intravenous
  Other Name: Taxotere®
• Drug: 5-fluorouracil
  intravenous
  Other Name: 5-FU
• Drug: Doxorubicin
  intravenous
• Drug: Cyclophosphamide
  intravenous

Study Arms

• 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 *

• Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681.
• Mackey JR, Martin M, Pienkowski T, Rolski J, Guastalla JP, Sami A, Glaspy J, Juhos E, Wardley A, Fornander T, Hainsworth J, Coleman R, Modiano MR, Vinholes J, Pinter T, Rodriguez-Lescure A, Colwell B, Whitlock P, Provencher L, Laing K, Walde D, Price C, Hugh JC, Childs BH, Bassi K, Lindsay MA, Wilson V, Rupin M, Houe V, Vogel C; TRIO/BCIRG 001 investigators. Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial. Lancet Oncol. 2013 Jan;14(1):72-80. doi: 10.1016/S1470-2045(12)70525-9. Epub 2012 Dec 12.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 29, 2008): 1491
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2010
• Actual Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Austria, Brazil, Canada, Czech Republic, Egypt, France, Germany, Greece, Hungary, Israel, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, United Kingdom, United States, Uruguay

Administrative Information

• NCT Number: NCT00688740
• Other Study ID Numbers: EFC6041; XRP6976D-316; BCIRG001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: ICD Study Director, Sanofi-aventis
• Original Responsible Party: Same as current
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Cancer International Research Group (CIRG)

Investigators

• Study Director: ICD; Sanofi

• PRS Account: Sanofi
• Verification Date: February 2011