Weekly Taxol Plus Xeloda® vs Taxotere q3wk Plus Xeloda® in the Treatment of Metastatic BC
|ClinicalTrials.gov Identifier: NCT00201435|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 20, 2008
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm||Drug: Paclitaxel weekly in combination with capecitabine Drug: Docetaxel every 3 week in combination with capecitabine||Phase 2 Phase 3|
Open labeled randomized multicentre phase II/III trial. It is intended to include patients who are not usually included into clinical trials because they are not having disease with measurable lesions. In breast cancer the bulk of patients with metastatic disease is presenting with bone metastases which is difficult to evaluate with respect to response. In this study it is one of the main objectives to include this kind of everyday patients that we see in the clinic.
Because of this we will be using TTF as the primary endpoint. Skeletal events requiring radiotherapy or major changes in pain medications are defined as treatment failures causing stop in treatment even in the absence of radiological findings.
A: weekly Taxol® plus Xeloda® on days 1-14 q 3w B: Taxotere® q 3w plus Xeloda® on days 1-14 q 3w
Patients are randomized equally between the two arms.
Concomitant therapy: Simultaneous use of bisphosphonates is allowed, if this treatment has been initiated at least four weeks before study entry.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weekly Taxol® Plus Xeloda® Versus Taxotere® Every Three Weeks Plus Xeloda® in the Treatment of Metastatic Breast Cancer A Phase II/III Study|
|Study Start Date :||March 2005|
|Primary Completion Date :||January 2008|
|Study Completion Date :||May 2008|
- Time to treatment failure
- Quality of life
- Response rates
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201435
|Ullevål university hospital|
|Oslo, Norway, 0407|
|Principal Investigator:||Erik Wist, MD, PhD|