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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.

NCT07207070 is registered in ClinicalTrials.gov with Risen (Suzhou) Pharma Tech Co., Ltd. as lead sponsor.

NCT NCT07207070
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Registry record

As filed in ClinicalTrials.gov.

Title
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.
Lead sponsor
Risen (Suzhou) Pharma Tech Co., Ltd.
Phase
Phase 3
Overall status
Recruiting
Start date
November 12, 2025
Completion date
May 31, 2030
Enrollment
312 (estimated)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

breast cancer