Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
| Condition(s) | Metastatic Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. |
| Who can participate | Inclusion Criteria: * Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF; * Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological samples; * Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage; * Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; * Expected survival ≥ 12 weeks; * Adequate organ and bone marrow function; * Patients who are eligible for a chemotherapy regimen in the control group; * Female patients of childbearing potential and male |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2023-10-31 |
| NCT ID | NCT06081959 |
| Official listing | https://clinicaltrials.gov/study/NCT06081959 |