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.
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.
• At the time of signing the consent form, age must be between 18 and 75 years old, males and females;
• Patients with unresectable PIK3CA-mutated HR-positive HER2-negative recurrent or metastatic breast cancer;
• Consent to provide tumour tissue or blood samples to determine the PIK3CA mutation status;
• ECOG 0 or 1;
• At least one measurable lesion as per RECIST v1.1, or only bone metastases;
• Expected survival≥12 weeks;
• Good organ function;
• Patients voluntarily join the study and sign the informed consent;