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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270491
|Hôpital HOTEL DIEU|
|Paris, France, 75004|
|Principal Investigator:||Rémy LARGILLIER, Physician||Centre ANTOINE LACASSAGNE - NICE (FRANCE)|