Study of Docetaxel in Breast Cancer Patients

Phase 3

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: epidoxorubicine, docetaxel, cyclophosphamide; Drug: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile; Drug: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile

• Registration Number: NCT00174707
• Lead Sponsor: Sanofi

Brief Summary

Primary objectives:

* To compare the disease free survival (DFS) in patients treated with the sequential epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin

Secondary objectives:

* To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and CMF (only patients with \> or = 4 lymph nodes) regimen to that in patients treated with sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen

* To evaluate the overall survival in each arm

* To evaluate the tolerability of a sequential intensified epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)

* To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen versus a standard sequential epidoxorubicin/CMF regimen (arm A)

Detailed Description

Not available

Study Timeline

• Study Start: 1997-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 998

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	epidoxorubicine, docetaxel, cyclophosphamide	Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)
A	epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile	Sequential Epidoxorubicin followed by CMF: ciclophosphamide/Methotrexate/fluorouracile (±TAM: tamoxifen)
B	epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile	Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)

Primary Outcome Measures

Name	Time	Method
Invasive Disease-Free Survival (IDFS) - with exclusion of ductal carcinoma in situ- DCIS- either collateral or ipsilateral, according to STEEP in adjuvant breast cancer trial: Standardized Definitions for Efficacy Endpoints	Time between randomization date and date of local or distant recurrence or contralateral breast cancer or second primary (non breast) cancer or death from any cause, whichever occurs first

Secondary Outcome Measures

Name	Time	Method
Recurrence-Free Survival (RFS)	Time between the date of randomization and the date of local or distant recurrence or death from any cause, whichever occurs first, thus excluding contralateral breast cancer or second primary (non breast) cancers
Overall Survival (OS)	Time between the date of randomization and date of death
Distant Disease-Free Survival (DDFS)	Time betwen the date of randomization and the date of distant recurrence or death from any cause, whichever occurs first

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇮🇹 Milan, Italy