A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
The schedule of treatment includes vinorelbine (30 mg/m2 on days 1 & 8 every 21 days) and
trastuzumab (8 mg/kg on day 1 and then 6 mg/kg every 21 days). Vinorelbine is planned for
maximum 9 cycles, while trastuzumab can be continued until progression. This study is a
single-stage phase 2 design, and patients eligible for response evaluation are required.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Andrea De Matteis, M.D.
NCI Naples, Division of Medical Oncology C
Italy: Ethics Committee