A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breas
This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy. |
| Who can participate | Inclusion Criteria: 1. Women aged 18-75 years. 2. ECOG performance status 0-1. 3. Menopausal status. 4. Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration. 5. At baseline, there must be at least one measurable, extracranial lesion that meets RECIST v1.1 criteria. 6. Expected survival \> 3 months. 7. Women of childbearing potential must agree to use highly effective contraceptive measures during the study treatment and for 6 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding. 8. Voluntarily agree to participate in this clinical trial, willing and able to comply with the study visi |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Locations | Tianjin, Tianjin Municipality, China |
| Start date | 2025-05-22 |
| NCT ID | NCT06974929 |
| Official listing | https://clinicaltrials.gov/study/NCT06974929 |