Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients
This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.
| Condition(s) | Unresectable or Metastatic Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy. |
| Who can participate | Inclusion Criteria: 1. Women aged 18-75 years with both ends included. 2. ECOG Physical status 0-1 points. 3. Patients with histologically confirmed metastatic or locally advanced breast cancer. 4. Dose-exploration stage: advanced stage has received at least 1 line of endocrine therapy progression in the past, efficacy extension stage: has not received any systemic treatment for advanced disease5. 5. Antitumor therapy with radiographically confirmed disease progression or receiving advanced first-line standard endocrine therapy with no clinical or radiographically confirmed disease progression. 6. At least one measurable extracranial lesion must be present. 7. Expected survival \>3 months. 8. The functional level of the organ must meet the requirements of the test. 9. Fertile female subjec |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Lead sponsor | Shandong Suncadia Medicine Co., Ltd. |
| Locations | Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China |
| Start date | 2023-12-20 |
| NCT ID | NCT06167694 |
| Official listing | https://clinicaltrials.gov/study/NCT06167694 |