Docetaxel in Node Positive Adjuvant Breast Cancer

Breast Cancer Clinical Trial

— TAX316  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688740
• Other study ID #: EFC6041
• Secondary ID: XRP6976D-316BCIR
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2008
• Last updated: February 14, 2011
• Start date: June 1997
• Est. completion date: January 2010

Study information

• Verified date: February 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of HealthCanada: Health CanadaSpain: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1491
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel
intravenous
• 5-fluorouracil
intravenous
• Doxorubicin
intravenous
• Cyclophosphamide
intravenous

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Austria	Sanofi-Aventis Administrative Office	Wien
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Canada	Sanofi-Aventis Administrative Office	Laval
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Egypt	Sanofi-Aventis Administrative Office	Cairo
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Greece	Sanofi-Aventis Administrative Office	Athens
Hungary	Sanofi-Aventis Administrative Office	Budapest
Israel	sanofi-aventis Administrative office	Natanya
Poland	Sanofi-Aventis Administrative Office	Warszawa
Portugal	Sanofi-Aventis Administrative Office	Porto Salvo
Slovakia	Sanofi-Aventis Administrative Office	Bratislava
South Africa	Sanofi-Aventis Administrative Office	Midrand
Spain	Sanofi-Aventis Administrative Office	Barcelona
Sweden	Sanofi-Aventis Administrative Office	Bromma
United Kingdom	Sanofi-aventis adminsitrative office	Guildford Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey
Uruguay	Sanofi-aventis administrative office	Montevideo

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Cancer International Research Group

Countries where clinical trial is conducted

United States,  Uruguay,  Argentina,  Austria,  Brazil,  Canada,  Czech Republic,  Egypt,  France,  Germany,  Greece,  Hungary,  Israel,  Poland,  Portugal,  Slovakia,  South Africa,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Disease-Free Survival Events	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.	up to 10 year follow-up	No
Secondary	Number of Participants With Overall Survival Events	Overall Survival - time from the date of randomization up to the date of death of any cause.	up to 10 year follow-up	No
Secondary	Number of Participants With Second Primary Malignancies (Toxicity)	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.	up to 10 year follow-up	Yes