A Randomized, Open-Label, Multiple-center, Phase II Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies

NCT04262804 Phase 2 UNKNOWN

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

Details

Lead sponsor	Zai Lab (Shanghai) Co., Ltd.
Phase	Phase 2
Status	UNKNOWN
Enrolment	123
Start date	2020-01-13
Completion	2023-12

Conditions

• Breast Cancer Metastatic

Interventions

• Margetuximab
• Trastuzumab
• Chosen Chemotherapy (Capecitabine)
• Chosen Chemotherapy (Vinorelbine )
• Chosen Chemotherapy (Gemcitabine )

Primary outcomes

• PFS assessed by BICR (RECIST 1.1) — Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020.
  the time from randomization date to the date of first documented disease progression or death from any cause, whichever occurs first. The confirmation of disease progression is per RECIST 1.1, and evaluation made by BICR

Countries

Taiwan