The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer

Sponsor
Bio-Thera Solutions
Study ID
NCT04185649
Phase
PHASE3
Status
Unknown

Conditions

  • HER2-positive Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BAT8001 for injection — BIOLOGICAL
    3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.
  • Lapatinib — DRUG
    Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.
  • Capecitabine — DRUG
    Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.

Study Details

To evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.

Key Dates

Start date
Jul 1, 2018
Status verified
Dec 2019
Primary completion
Jul 31, 2020
Completion
Dec 31, 2021

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BAT8001 for injection
    Participants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with trastuzumab emtansine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.
  • Active Comparator: Control (lapatinib + capecitabine)
    Participants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with lapatinib plus capecitabine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to approximately 18 months ]

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