A Study of Pyrotinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This
study is a randomized, multi-center, multinational, double blind, active-controlled, parallel
design study of the combination of pyrotinib in combination with capecitabine versus placebo
plus capecitabine in HER2+ MBC patients, who have prior received anthracyclin, taxane and
trastuzumab.
Patients will be randomized in a 2:1 ratio to one of the following treatment arms:
Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Arm B: placebo
(400 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients will receive either arm
of therapy until the occurrence of death, disease progression, unacceptable toxicity, or
other specified withdrawal criterion.
Patients in control group can be provide pyrotinib treatment when they progressed after the
placebo plus capecitabine treatment.