NCT05949541
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer
Recruiting · Phase 2 · Fudan University · registry updated 2024-02-08
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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;
Exclusion
- Patients with any of the following conditions were excluded from the study
- Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol).
- A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
- Radiotherapy, chemotherapy, surgery, other targeted therapy and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks prior to first administration of drugs used in this study.
- Pregnant or lactating patients;
- Other malignancies within the previous 3 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ;