clinical trial · 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.
Risen (Suzhou) Pharma Tech Co., Ltd.·phase3·recruiting·n = 312
Breast CancerJS105DalpiciclibFulvestrant 50 Mg/mL Intramuscular Solution
brief 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.
started
Nov 12, 2025
primary completion
May 31, 2029
completion
May 31, 2030
last updated
Dec 30, 2025
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol