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

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

Timeline

Start

2020-01-13

Primary completion

2021-09-03

Completion

2023-12

Outcome

Met primary endpoint

paper with a hazard ratio (HR) of 0.69 [95% confidence interval (CI): 0.43-1.12], which met the consistency criterion (HR <0.88) for bridging success. PMID 38751523 ↗

Publications

• Zhang Q, Ouyang Q, Li W, Chiu J, Yan M, Lu YS, Sun S, Li H, Du Y, Wang X, Sun T, Yin Y, Wang H, Ye F, Shen K, Wang J, Pan Y, Wang S, Yang J, Wu X, Dai MS, Cheng J, Teng Y, Su F, Wu X, He J, Fu P, Yang L, Xin Y, Wang X, Jiang Z. Efficacy and safety of margetuximab plus chemotherapy vs. trastuzumab plus chemotherapy in Chinese patients with pretreated HER2-positive advanced metastatic breast cancer: results from a randomized, open-label, multicenter, phase II bridging study. Transl Breast Cancer Res. 2022 Oct 31;3:31. doi: 10.21037/tbcr-22-35. eCollection 2022.

Drugs

Indications