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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Docetaxel; Drug: 5-fluorouracil; Drug: Doxorubicin; Drug: Cyclophosphamide	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1491 participants
• 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.
• Study Start Date: June 1997
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: January 2010

Arms and Interventions

Arm	Intervention/treatment
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; intravenous; Other Name: Taxotere®; Drug: Doxorubicin; intravenous; Drug: Cyclophosphamide; intravenous
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; intravenous; Other Name: 5-FU; Drug: Doxorubicin; intravenous; Drug: Cyclophosphamide; intravenous

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New Jersey

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States, 08807

Argentina

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Austria

Sanofi-Aventis Administrative Office

Wien, Austria

Brazil

Sanofi-Aventis Administrative Office

Sao Paulo, Brazil

Canada

Sanofi-Aventis Administrative Office

Laval, Canada

Czech Republic

Sanofi-Aventis Administrative Office

Praha, Czech Republic

Egypt

Sanofi-Aventis Administrative Office

Cairo, Egypt

France

Sanofi-Aventis Administrative Office

Paris, France

Germany

Sanofi-Aventis Administrative Office

Berlin, Germany

Greece

Sanofi-Aventis Administrative Office

Athens, Greece

Hungary

Sanofi-Aventis Administrative Office

Budapest, Hungary

Israel

sanofi-aventis Administrative office

Natanya, Israel

Poland

Sanofi-Aventis Administrative Office

Warszawa, Poland

Portugal

Sanofi-Aventis Administrative Office

Porto Salvo, Portugal

Slovakia

Sanofi-Aventis Administrative Office

Bratislava, Slovakia

South Africa

Sanofi-Aventis Administrative Office

Midrand, South Africa

Spain

Sanofi-Aventis Administrative Office

Barcelona, Spain

Sweden

Sanofi-Aventis Administrative Office

Bromma, Sweden

United Kingdom

Sanofi-aventis adminsitrative office

Guildford Surrey, United Kingdom

Uruguay

Sanofi-aventis administrative office

Montevideo, Uruguay

Sponsors and Collaborators

Sanofi

Cancer International Research Group (CIRG)

Investigators

• Study Director: ICD; Sanofi

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: ICD Study Director, Sanofi-aventis
• ClinicalTrials.gov Identifier: NCT00688740
• Other Study ID Numbers: EFC6041; XRP6976D-316; BCIRG001
• First Posted: June 3, 2008
• Results First Posted: February 14, 2011
• Last Update Posted: February 16, 2011
• Last Verified: February 2011

Keywords provided by Sanofi:

adjuvant treatment

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Cyclophosphamide; Docetaxel; Doxorubicin; Fluorouracil; 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; Antimetabolites, Antineoplastic