Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer
Status:
Completed
Trial end date:
2015-10-19
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine if AMG 386 in combination with either paclitaxel
and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with
HER2-positive locally recurrent or metastatic breast cancer.
This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation
study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab
(cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of
the tolerable doses determined in part 1.