Clinical Trial

SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment

Study acronym: SHINE-HER
Recruiting Phase 2
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Summary
This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer following progression on prior T-DXd therapy.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-13.
Trial Details
NCT Number NCT07182721
Lead Sponsor Fudan University
Conditions HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer, SKB264, Inetetamab
Enrollment 48 participants
Start Date 2025-09-30
Primary Completion 2028-09-30 (estimated)
Study Completion 2029-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-15