Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment
Status:
Completed
Trial end date:
2014-08-31
Target enrollment:
Participant gender:
Summary
AIM OF STUDY
Primary Efficacy Variable:
The primary study objective is the proof of efficacy, measured by progression free survival
(PFS) in the treatment of metastatic or locally inoperable recurrent breast cancer.
Progression-free survival (PFS) is defined as the time from randomisation to disease
progression or death.
Secondary Efficacy Variables:
- Clinical benefit (CR+PR+SD)
- ORR (CR+PR)
- Time to progression
- Time to next Treatment (TTT)
- Overall survival
- Safety profile
Phase:
Phase 2
Details
Lead Sponsor:
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH