A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

Sponsor
RemeGen Co., Ltd.
Study ID
NCT03500380
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • RC48-ADC — DRUG
    RC48-ADC 2.0 mg/kg IV every 14 days
  • Lapatinib — DRUG
    Lapatinib 1250 mg orally once daily during each 21-day cycle.
  • Capecitabine — DRUG
    Capecitabine 2000 mg/m\^2 orally daily on Days 1-14 of each 21-day treatment cycle.

Study Details

This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.

Key Dates

Start date
Apr 24, 2018
Status verified
Nov 2023
Primary completion
Jul 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
301 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: RC48-ADC
    Participants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
  • Active Comparator: Lapatinib + Capecitabine
    Participants will receive lapatinib 1250 mg orally once daily during each 21-day cycle + capecitabine 2000 mg/m\^2 orally daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.

Primary Outcome Measure

Progression-free Survival (PFS) as Assessed by an IRC [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]

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