Phase I/II Study of Lapatinib in Combination With Paclitaxel as 1L Chemotherapy for ErbB2-positive MBC
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
This is an open-label, non-randomized, multi-center study of lapatinib plus paclitaxel to
evaluate safety, tolerability and efficacy in Japanese patients with ErbB2 over expressing
advanced or metastatic breast cancer. Lapatinib 1500mg/day will be administered in
combination with paclitaxel 80mg/m2/week. Lapatinib and paclitaxel will be administered until
disease progression or withdrawal from the study due to unacceptable toxicity.
The study will proceed in two phases. The first phase (Phase I part) will lead to evaluate
safety and tolerability of lapatinib taken together with paclitaxel in the first 6 subjects.
Pharmacokinetic profile also will be evaluated as the secondary objects.
Then the study will move to the next treatment phase (Phase II part) to evaluate further
safety and clinical activity, if no major safety concerns are raised during Phase I part. The
primary objective of the study is to evaluate overall survival (OS), and the secondary
objectives are Objective tumour response rate (ORR), Duration of response, Time to response,
Clinical benefit and Progression-free survival (PFS) in 12 subjects.