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.

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

November 28, 2025

Primary Completion Date

May 31, 2029

Study Completion Date

May 31, 2030

Conditions
Breast Cancer
Interventions
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.

Trial Locations (2)

100021

Chinese Acadamy of Medical Sciences and Peking Union Medical College, Beijing

450003

Henan Provincial Cancer Hospital, Zhengzhou

All Listed Sponsors
lead

Risen (Suzhou) Pharma Tech Co., Ltd.

INDUSTRY