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Study of Docetaxel in Breast Cancer Patients

NCT00174707 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 998

Last updated 2009-12-07

No results posted yet for this study

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)

Conditions

  • Breast Neoplasms

Interventions

DRUG

epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile

Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM)

DRUG

epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile

Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)

DRUG

epidoxorubicine, docetaxel, cyclophosphamide

Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)

Sponsors & Collaborators

Principal Investigators

  • Georges Paizis, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-12-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00174707 on ClinicalTrials.gov