Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer
The administration of vinorelbine and capecitabine had been implied to be quite useful in
metastatic breast cancer. This study was designed to explore whether sequential and
simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the
sequential way has better tolerability.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause)
PFS was assessed every two cycles (3 weeks per cycle)and during the follow up time, by serum tumor markers, physical examination and image examination, until disease progression event occurs. If a patient has the sign or hint of disease progression, then the lab examination, physical examination or image examination could be taken at any time.
Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs.
XiChun Hu, MD, PhD
China: Ethics Committee