Clinical Trial

A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.

Recruiting Phase 3
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Summary
This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with PIK3CA-mutated, HR-positive, HER2-negative recurrent or metastatic breast cancer.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-26.
Status change: Not Yet Recruiting → Recruiting 2025-12-22
Trial Details
NCT Number NCT07207070
Lead Sponsor Risen (Suzhou) Pharma Tech Co., Ltd.
Conditions Breast Cancer
Enrollment 312 participants
Start Date 2025-11-12
Primary Completion 2029-05-31 (estimated)
Study Completion 2030-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-30