BIG 02/98 Docetaxel - Breast Cancer

Status Completed

Clinical Trial Summary

Primary objectives:

- To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes.

Secondary objectives:

- To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes

- To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes

- To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus polychemotherapy).

- To compare overall survival of treatment arms.

- To compare toxicity of treatment arms.

- To evaluate pathologic and molecular markers for predicting efficacy.

- Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Breast Neoplasms

Clinical Trial Details

NCT number	NCT00174655
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 3
Start date	June 1998
Completion date	September 2011

View Details

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