Lapatinib + Vinorelbine in ErbB2 Overexpressing, First or Second Line Metastatic Breast Cancer Subjects
Status:
Terminated
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
This is an open-label, single-arm, multi-center, Phase II study to determine the activity of
vinorelbine plus lapatinib in either first- or second-line setting in women with ErbB2
overexpressing metastatic breast cancer (MBC). Sixty subjects will be enrolled in the study.
Subjects will receive vinorelbine intravenously once weekly for 3 weeks, followed by a rest
week in a 4-week cycle) plus lapatinib daily. Subjects will receive treatment until disease
progression or withdrawal from the study. The primary objective of this study is to evaluate
overall tumor response rate of lapatinib in combination with vinorelbine. Secondary
objectives include progression-free survival, overall survival, duration of response, time to
response and time to progression and safety. Safety and efficacy assessments will be
performed at 4, 8 and 12 week intervals, and at the end of treatment.
Subject: Metastatic Breast Cancer, ErbB2, First-line or Second-line therapy, Lapatinib,
Vinorelbine