Docetaxel in Node Positive Adjuvant Breast Cancer
Overview[ - collapse ][ - ]
| Purpose | 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 | Breast Cancer |
| Intervention | Drug: Docetaxel Drug: 5-fluorouracil Drug: Doxorubicin Drug: Cyclophosphamide |
| Phase | Phase 3 |
| Sponsor | Sanofi |
| Responsible Party | Sanofi |
| ClinicalTrials.gov Identifier | NCT00688740 |
| First Received | May 29, 2008 |
| Last Updated | February 14, 2011 |
| Last verified | February 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 29, 2008 |
|---|---|
| Last Updated Date | February 14, 2011 |
| Start Date | June 1997 |
| Estimated Primary Completion Date | January 2010 |
| Current Primary Outcome Measures | 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. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| 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, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Breast Cancer |
| Intervention | Drug: Docetaxel intravenous Other Names: Taxotere®Drug: 5-fluorouracil intravenous Other Names: 5-FUDrug: Doxorubicin intravenous Drug: Cyclophosphamide intravenous |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 1491 |
| Estimated Completion Date | January 2010 |
| Estimated Primary Completion Date | January 2010 |
| 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. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Argentina, Austria, Brazil, Canada, Czech Republic, Egypt, France, Germany, Greece, Hungary, Israel, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, United Kingdom, Uruguay |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00688740 |
|---|---|
| Other Study ID Numbers | EFC6041 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Sanofi |
| Study Sponsor | Sanofi |
| Collaborators | Cancer International Research Group |
| Investigators | Study Director: ICD Sanofi |
| Verification Date | February 2011 |
Locations[ + expand ][ + ]
| Sanofi-Aventis Administrative Office | Bridgewater, New Jersey, United States, 08807 |
|---|---|
| Sanofi-Aventis Administrative Office | Buenos Aires, Argentina |
| Sanofi-Aventis Administrative Office | Wien, Austria |
| Sanofi-Aventis Administrative Office | Sao Paulo, Brazil |
| Sanofi-Aventis Administrative Office | Laval, Canada |
| Sanofi-Aventis Administrative Office | Praha, Czech Republic |
| Sanofi-Aventis Administrative Office | Cairo, Egypt |
| Sanofi-Aventis Administrative Office | Paris, France |
| Sanofi-Aventis Administrative Office | Berlin, Germany |
| Sanofi-Aventis Administrative Office | Athens, Greece |
| Sanofi-Aventis Administrative Office | Budapest, Hungary |
| sanofi-aventis Administrative office | Natanya, Israel |
| Sanofi-Aventis Administrative Office | Warszawa, Poland |
| Sanofi-Aventis Administrative Office | Porto Salvo, Portugal |
| Sanofi-Aventis Administrative Office | Bratislava, Slovakia |
| Sanofi-Aventis Administrative Office | Midrand, South Africa |
| Sanofi-Aventis Administrative Office | Barcelona, Spain |
| Sanofi-Aventis Administrative Office | Bromma, Sweden |
| Sanofi-aventis adminsitrative office | Guildford Surrey, United Kingdom |
| Sanofi-aventis administrative office | Montevideo, Uruguay |