Docetaxel in Node Positive Adjuvant Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: 5-fluorouracil; Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide

• Registration Number: NCT00688740
• Lead Sponsor: Sanofi

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 Timeline

• Study Start: 1997-06
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-06-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2011-01-25
• Results First Submitted QC: 2011-01-25
• Status Verified: 2011-02
• Results First Posted: 2011-02-14
• Last Update Submitted: 2011-02-14
• Last Update Posted: 2011-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1491

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FAC (5-fluorouracil)	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
FAC (5-fluorouracil)	Cyclophosphamide	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
TAC (Docetaxel)	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
TAC (Docetaxel)	Doxorubicin	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
TAC (Docetaxel)	Cyclophosphamide	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
FAC (5-fluorouracil)	Doxorubicin	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Disease-Free Survival Events	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

Name	Time	Method
Number of Participants With Overall Survival Events	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)	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.

Trial Locations

Locations (4)

sanofi-aventis Administrative office; 🇮🇱 Natanya, Israel

Sanofi-aventis adminsitrative office; 🇬🇧 Guildford Surrey, United Kingdom

Sanofi-Aventis Administrative Office; 🇸🇪 Bromma, Sweden

Sanofi-aventis administrative office; 🇺🇾 Montevideo, Uruguay