Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subty
This is a randomized, controlled, open-label, phase II study to explore the efficacy and safety of Everolimus in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF1 subtype of advanced breast cancer. The study was used to explore the efficacy of Everolimus in combination with standard endocrin
| Condition(s) | Breast Cancer, Advanced Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a randomized, controlled, open-label, phase II study to explore the efficacy and safety of Everolimus in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF1 subtype of advanced breast cancer. The study was used to explore the efficacy of Everolimus in combination with standard endocrine therapy. |
| Who can participate | Inclusion Criteria: * Patients need to meet all of the following conditions * Patients must be ≥18 and ≤ 75 years of age; * Pathologically confirmed breast cancer is HR+/HER2- breast cancer (IHC ER \>10%, or/and PR\>10%, HER 0 OR +, if HER2++, FISH negative); * SNF1 subtype definition: SNF1 subtype confirmed by digital pathology of H\&E sections; * Locally advanced breast cancer (radical local therapy is not possible) or metastatic breast cancer (without using adjuvant CDK4/6 inhibitors in the past, or one year after adjuvant CDK4/6 inhibitor therapy has ended); * No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer; * Patients with at least one measurable lesion that has not previously received radiation therapy and can be evaluated repeatedly a |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Lead sponsor | Fudan University |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2023-07-26 |
| NCT ID | NCT05949541 |
| Official listing | https://clinicaltrials.gov/study/NCT05949541 |