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

NCT04262804 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2023-08-22

No results posted yet for this study

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

Conditions

  • Breast Cancer Metastatic

Interventions

DRUG

Margetuximab

Margetuximab IV

DRUG

Trastuzumab

Trastuzumab IV

DRUG

Chosen Chemotherapy (Capecitabine)

Capecitabine tablet

DRUG

Chosen Chemotherapy (Vinorelbine )

Vinorelbine IV

DRUG

Chosen Chemotherapy (Gemcitabine )

Gemcitabine IV

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2021-09-03
Completion
2023-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262804 on ClinicalTrials.gov