Docetaxel in Node Positive Adjuvant Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: 5-fluorouracil
* Drug: Doxorubicin
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAC (Docetaxel)<br>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<br>* intravenous<br>* Other names: Taxotere®;Drug: Doxorubicin<br>* intravenous<br>Drug: Cyclophosphamide<br>* intravenous<br>|
| Active Comparator: FAC (5-fluorouracil)<br>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<br>* intravenous<br>* Other names: 5-FU;Drug: Doxorubicin<br>* intravenous<br>Drug: Cyclophosphamide<br>* intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjuvant treatment