A Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients
Status:
Terminated
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
The objective of this phase II study is to gain first information on the efficacy (PFS, ORR
and OS) and safety of lapatinib plus vinorelbine in patients with HER2 positive metastatic
breast cancer pretreated with a combination therapy (chemotherapy and/or hormonal therapy)
including lapatinib and presenting with tumor progression.
Primary objective is to assess the efficacy with respect to the percentage of patients
surviving without disease progression as assessed by RECIST criteria.
Secondary objectives are to assess the efficacy of the study treatment with respect to the
objective response rates as assessed by RECIST criteria version 1.1, the overall survival and
to evaluate the safety profile of the combination by recording the adverse events and
abnormal laboratory values associated with the study treatments.
The main efficacy endpoints will be investigated both for the intent-to-treat (ITT)
population and the per-protocol (PP) population.