RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure

Sponsor
Fudan University
Study ID
NCT07366840
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Disitamab Vedotin — DRUG
    2.0mg/kg every two weeks
  • Gemcitabine — DRUG
    1000mg/m2 on days 1 and 8 every three weeks
  • Capecitabine — DRUG
    1000 mg/m2 twice daily on days 1 to14 every three weeks
  • Trastuzumab — DRUG
    6 mg/kg once every three weeks, with an initial loading dose of 8 mg/kg
  • Inetetamab — DRUG
    6 mg/kg once every three weeks, with an initial loading dose of 8 mg/kg

Study Details

The purpose of this study is to assess the safety and efficacy of RC48 (a HER2 antibody drug conjugate with MMAE payload) in combination with gemcitabine or capecitabine (with or without trastuzumab/inetetamab), for treatment of patients with HER2-positive advanced breast cancer (ABC) who have developed disease progression or intolerance to prior therapy with a topoisomerase I inhibitor antibody-drug conjugate (TOP1i-ADC).

Key Dates

First listed
Jan 26, 2026
Start date
Jan 16, 2026
Status verified
Jan 2026
Primary completion
Jan 16, 2028
Completion
Jan 16, 2029

Study Design

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

Arms

  • Experimental: Disitamab Vedotin plus chemo
    Participants received Disitamab Vedotin (RC48), 2.0mg/kg intravenously on day 1 of two-week cycle, plus chemotherapy of physician's choice (gemcitabine 1000mg/m2, intravenously on days 1 and 8 of 21-day cycle, or capecitabine, 1000 mg/m2, orally twice daily on days 1-14 of 21-day cycle), with or without guideline-recommended anti-HER2 monoclonal antibody (Trastuzumab or Inetetamab (an analog of trastuzumab), 8 mg/kg loading dose, intravenously, then 6 mg/kg without loading dose, on day 1 of 21-day cycle) until physician's verified progression or unacceptable toxicity.
  • Experimental: Trastuzumab plus chemo
    Participants received chemotherapy of physician's choice (gemcitabine 1000mg/m2, intravenously on days 1 and 8 of 21-day cycle, or capecitabine, 1000mg/m2, orally twice daily on days 1-14 of 21-day cycle), with or without guideline-recommended anti-HER2 monoclonal antibody (Trastuzumab or Inetetamab (an analog of trastuzumab), 8 mg/kg loading dose, intravenously, then 6 mg/kg without loading dose, on day 1 of 21-day cycle) until physician's verified progression or unacceptable toxicity.

Primary Outcome Measure

Median progression free survival (by investigator) [ Time Frame: The observation period for this endpoint is up to 36 months, and will be terminated early upon disease progression or death. ]

Central Contacts

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