A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy an
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.
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. At the time of signing the consent form, age must be between 18 and 75 years old, males and females; 2. Patients with unresectable PIK3CA-mutated HR-positive HER2-negative recurrent or metastatic breast cancer; 3. Consent to provide tumour tissue or blood samples to determine the PIK3CA mutation status; 4. ECOG 0 or 1; 5. At least one measurable lesion as per RECIST v1.1, or only bone metastases; 6. Expected survival≥12 weeks; 7. Good organ function; 8. Patients voluntarily join the study and sign the informed consent; Exclusion Criteria: 1. Previously treated with fulvestrant or PI3K/AKT/mTOR inhibitors; 2. Presence of untreated or active central nervous system (CNS) metastases; 3. Presence of significant clinical symptoms or uncontrolled pleural effusion, ascites, |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Risen (Suzhou) Pharma Tech Co., Ltd. |
| Locations | Beijing, Beijing Municipality, China; Zhengzhou, Henan, China |
| Start date | 2025-11-12 |
| NCT ID | NCT07207070 |
| Official listing | https://clinicaltrials.gov/study/NCT07207070 |