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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	JS105	Patients will receive oral JS105 on Days 1-28 of each 4-week cycle.
DRUG	Dalpiciclib	Patients will receive oral Dalpiciclib for 3 weeks, followed by 1 week off in each 4-week cycle；
DRUG	Fulvestrant 50 Mg/mL Intramuscular Solution	Patients will receive intramuscular Fulvestrant on day 1 and day 15 of the first cycle and then on day 1 of each subsequent 4-week cycle.

Timeline

• Start date: 2025-11-12
• Primary completion: 2029-05-31
• Completion: 2030-05-31
• First posted: 2025-10-03
• Last updated: 2025-12-30

Locations

2 sites across 1 country: China