Overview

A Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ MBC

Status:
Recruiting

Trial end date:
2021-09-01

Target enrollment:

Participant gender:

Summary

This is a randomized, open-label, multi-center, Phase II clinical study to evaluate the efficacy and safety of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in Chinese patients (Mainland, Hong Kong and Taiwan) with advanced HER2+ breast cancer who have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting (mandatory including trastuzumab). The primary endpoint of this study is PFS evaluated by BICR. The secondary endpoints are OS, PFS evaluated by investigator, ORR, DoR, CBR, safety and tolerability, the impact of ADA, and the popPK profile

Phase:

Phase 2

Details

Lead Sponsor:

Zai Lab (Shanghai) Co., Ltd.

Treatments:

Antibodies, Monoclonal
Capecitabine
Gemcitabine
Margetuximab
Trastuzumab
Vinorelbine