Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Trastuzumab

Vinorelbine

Margetuximab

Antimetabolites

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

The dosage and administering of margetuximab is 15 mg/kg IV every 21 days. Investigators need to chose one of the 3 chemotherpies based on patient conditions.

The dosage and administering of Trastuzumab is 8 mg/kg loading dose then 6 mg/kg IV every 21 days. Investigators need to chose one of the 3 chemotherpies based on patient conditions.

Chosen Chemotherapy (Capecitabine)

Chosen Chemotherapy (Vinorelbine )

Chosen Chemotherapy (Gemcitabine )

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

Approximately 120 Chinese subjects will be enrolled and randomized to treatment group and control group in 1:1 fashion, approximately 60 subjects in each group. Eligible subjects are HER2 positive, metastatic breast cancer who has received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting (mandatory to have trastuzumab, and other anti-HER2 agents e.g. lapatinib, pyrotinib, and pertuzumab; in case of having received (neo)adjuvant anti-HER2 therapy) in Chinese patients (Mainland, Hong Kong and Taiwan). Subjects should Have received treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting (including anti-HER2 directed therapy and chemotherapy, and patients must have progressed on or following, the most recent line of therapy, based on RECIST 1.1.

Eligible subjects will be randomized 1:1 to receive margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy. The dosage and administering of margetuximab is 15 mg/kg IV Q3W. Trastuzumab was administered 8 mg/kg loading dose, 6 mg/kg subsequent doses, IV Q3W. Prior to randomization to either margetuximab or trastuzumab, investigators selected one of four backbone chemotherapy regimens given at standard doses: capecitabine, vinorelbine or gemcitabine. Capecitabine and vinorelbine should be selected in priority. Gemcitabine could be selected only if capecitabine and vinorelbine were used in previous treatment. Subject will receive the treatment until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anti-tumor treatment therapy, or death (whichever occurs first). Subject is not allowed to crossover after disease progression. Randomization was stratified by number of metastatic sites (≤2, \>2) and chemotherapy chosen.

The definition of HER2 positive is to have at least once 3+ by IHC, FISH positive or CISH positive in the pathological test/retesting. Subject should provide original biopsy/surgical excision tissue sample/latest follow-up sample after randomization, for the centralized test and review when necessary.

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

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

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

the time from randomization date to the date of death from any cause

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 investigator

the proportion of subjects in the response evaluable population achieving a best response of CR or PR when such responses are confirmed 6 weeks after initial observation of response. Subjects who have no assessment will be considered as non-responders

the proportion of subjects in the response evaluable population achieving a best response of CR, PR, or SD

To evaluate the effects of allelic variation in FcγR on the efficacy of margetuximab in all patients receiving study treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ MBC	NCT04262804	Breast Cancer M...	Margetuximab Trastuzumab Chosen Chemothe... Chosen Chemothe... Chosen Chemothe...	18 Years -	Zai Lab (Hong Kong), Ltd.
A Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ MBC	NCT04262804	Breast Cancer M...	Margetuximab Trastuzumab Chosen Chemothe... Chosen Chemothe... Chosen Chemothe...	18 Years -	Zai Lab (Hong Kong), Ltd.
A Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ MBC	NCT04262804	Breast Cancer M...	Margetuximab Trastuzumab Chosen Chemothe... Chosen Chemothe... Chosen Chemothe...	18 Years -	Zai Lab (Hong Kong), Ltd.

Spots Global Cancer Trial Database for chosen chemotherapy (capecitabine)