Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study
The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has
improved survival in patients with Her-2 positive metastatic breast cancer, but newer
combinations with less toxicity and cross resistance are needed. Early clinical studies have
suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active
against metastatic breast cancer, with less toxicity. In this phase II single center trial,
39 patients will be enrolled to evaluate the activity and safety of this combination.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
objective response rate
after 3 and 6 cycles of therapy
Andrea De Matteis, M.D.
NCI Naples, Division of Medical Oncology C
Italy: Ethics Committee