Recruiting PHASE3 NCT07207070
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.
Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd.
Conditions
Breast Cancer
Interventions
Dalpiciclib Fulvestrant 50 Mg/mL Intramuscular Solution JS105
Updated 2 times since 2025 Last updated: Dec 22, 2025 Started: Nov 12, 2025 Primary completion: May 31, 2029 Completion: May 31, 2030
Listed as NCT07207070, this PHASE3 trial focuses on Breast Cancer and remains actively recruiting participants. Sponsored by Risen (Suzhou) Pharma Tech Co., Ltd., it has been updated 2 times since 2025, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Change History
2 versions recorded-
Jan 2026 — Present [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
-
Nov 2025 — Jan 2026 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
Sponsor contact:
- Risen (Suzhou) Pharma Tech Co., Ltd.
Data source: Risen (Suzhou) Pharma Tech Co., Ltd.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
- • Beijing, China
- • Zhengzhou, China