Weekly Taxol® Plus Xeloda® Versus Taxotere® Every Three Weeks Plus Xeloda® in the Treatment of Metastatic Breast Cancer A Phase II/III Study
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to treatment failure
Erik Wist, MD, PhD
Norway: Norwegian Medicines Agency