ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib
Status:
Terminated
Trial end date:
2019-10-21
Target enrollment:
Participant gender:
Summary
This study was originally designed as a Phase III randomized, double blind, placebo
controlled study to assess the safety and tolerability, and efficacy of paclitaxel plus
trastuzumab plus lapatinib compared with paclitaxel plus trastuzumab plus placebo in women
with ErbB2 overexpressing metastatic breast cancer. The planned study was a two stage design
with an initial open-label safety stage to be conducted in approximately 65 subjects followed
by a randomized phase conducted in a further 700 subjects. The open-label part of the study
sequentially enrolled three cohorts with patients receiving a different dose combination of
paclitaxel, trastuzumab and lapatinib. Following poor recruitment rate in the open label
stage, the randomized stage of the study was terminated, thus no subjects were enrolled into
the randomization stage.