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NCT07366840Possibly a fitNot yet recruiting

RC48 with chemotherapy for HER2-positive advanced breast cancer

HER2-positive Breast CancerMetastatic Breast Cancer

Treatments studied

Part of Cancer, Skin clinical trials.

This trial tests whether combining the drug RC48 with chemotherapy can help people whose HER2-positive advanced breast cancer has stopped responding to a prior type of antibody-drug conjugate (ADC) therapy. It may offer a new treatment option for those whose cancer has progressed after previous treatments.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
268 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must be a woman aged 18 or older.
  • Your cancer must be HER2-positive (tested with IHC 3+ or IHC 2+ and FISH positive) and advanced (has spread or cannot be removed by surgery).
  • Your cancer must have worsened while on or after treatment with a type of targeted therapy called a TOP1i-ADC (like T-DXd or sacituzumab govitecan).
  • You must have had no more than 3 previous treatments for advanced disease, and only one type of ADC before.
  • You must have at least one measurable tumor outside the brain that can be evaluated by scans.
  • You must have good overall health, with an ECOG performance status of 0 or 1, and adequate organ function (blood counts, liver, kidneys).
  • If you can become pregnant, you must use medically approved contraception during the study and for at least 3 months after the last dose.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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