A phase 3 trial testing JS105 in HR-positive / HER2-negative breast cancer, now recruiting.
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 is a phase 3 interventional study registered as NCT07207070, led by Risen (Suzhou) Pharma Tech, and recruiting on the registry. Official 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. Planned enrolment is 312 participants (estimated). The study started in 2025-11-12 and primary completion is expected in 2029-05-31. No results have been posted on ClinicalTrials.gov.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares JS105, Shanghai Junshi Biosciences.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, HR-positive / HER2-negative breast cancer.
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