Docetaxel in Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel,doxorubicin, cyclophosphamide; Drug: docetaxel, doxorubicin, cyclophosphamide

• Registration Number: NCT00312208
• Lead Sponsor: Sanofi

Brief Summary

Primary objective :

* To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes.

Secondary objectives :

* To compare toxicity and quality of life between the 2 above-mentioned arms.

* To evaluate pathologic and molecular markers for predicting efficacy.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2006-04-05
• Study First Submitted QC: 2006-04-05
• Study First Posted: 2006-04-07
• Primary Completion: 2008-10
• Results First Submitted: 2009-10-29
• Results First Submitted QC: 2010-02-15
• Results First Posted: 2010-02-17
• Study Completion: 2013-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-04
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3299

Inclusion Criteria

Not provided

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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
1	Docetaxel,doxorubicin, cyclophosphamide	Doxorubicin in combination with cyclophosphamide followed by docetaxel (AC -\> T)
2	docetaxel, doxorubicin, cyclophosphamide	Docetaxel in combination with doxorubicin and cyclophosphamide (TAC)

Primary Outcome Measures

Name	Time	Method
Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)	Median follow-up 65 months	The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.

Secondary Outcome Measures

Name	Time	Method
Death From Any Cause (Overall Survival)	Median follow-up of 65 months	The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.

Trial Locations

Locations (2)

Sanofi-Aventis; 🇻🇪 Caracas, Venezuela

Sanofi-aventis; 🇳🇿 Auckland, New Zealand