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 · clinicaltrials.gov ↗

PHASE3

Phase

RECRUITING

Status

312

Enrollment

INDUSTRY

Sponsor class

Conditions

Breast Cancer

Interventions

DRUG: JS105
DRUG: Dalpiciclib
DRUG: Fulvestrant 50 Mg/mL Intramuscular Solution

Sponsor

Risen (Suzhou) Pharma Tech Co., Ltd.