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

Sponsor
Zai Lab (Shanghai) Co., Ltd.
Study ID
NCT04262804
Phase
PHASE2
Status
Unknown

Conditions

  • Breast Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Margetuximab — DRUG
    Margetuximab IV
  • Trastuzumab — DRUG
    Trastuzumab IV
  • Chosen Chemotherapy (Capecitabine) — DRUG
    Capecitabine tablet
  • Chosen Chemotherapy (Vinorelbine ) — DRUG
    Vinorelbine IV
  • Chosen Chemotherapy (Gemcitabine ) — DRUG
    Gemcitabine IV

Study Details

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

Key Dates

Start date
Jan 13, 2020
Status verified
Aug 2023
Primary completion
Sep 3, 2021
Completion
Dec 31, 2023

Study Design

Enrollment
123 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Margetuximab & Chosen Chemotherapy
    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.
  • Active Comparator: Trastuzumab & Chosen Chemotherapy
    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.

Primary Outcome Measure

PFS assessed by BICR (RECIST 1.1) [ Time Frame: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020. ]

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