Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.
Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Randomized Phase II Study Evaluating Tolerance and Efficacy of Capecitabine 5/7 Days With Weekly Paclitaxel Versus the Recommended Treatment Plan of Weekly Paclitaxel-capecitabine, in Patients With Metastatic Breast Cancer.|
- tolerance of the patients in the both groups.
- - Response rates and duration of response.
- - Haematological and non-haematological toxicities.
- - Progression free survival.
- - Overall survival.
|Study Start Date:||December 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
The purpose of this study is to know if we can optimize in term of tolerance even of efficacy the plan of administration of weekly paclitaxel associated with capecitabine.