Docetaxel in Node Positive Adjuvant Breast Cancer (TAX316)
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|ClinicalTrials.gov Identifier: NCT00688740|
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : February 14, 2011
Last Update Posted : February 16, 2011
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Docetaxel Drug: 5-fluorouracil Drug: Doxorubicin Drug: Cyclophosphamide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1491 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
Other Name: Taxotere®Drug: Doxorubicin
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
Other Name: 5-FUDrug: Doxorubicin
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688740
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