OncoMatch/Clinical Trials/NCT05949541
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer
Is NCT05949541 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Everolimus 10 mg and CDK4/6 Inhibitor SHR6390 for breast cancer.
Treatment: Everolimus 10 mg · CDK4/6 Inhibitor SHR6390 · Aromatase inhibitor and Fulvestrant combined with CDK4/6 inhibitors — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (IHC ER >10%)
IHC ER >10%
Required: PR (PGR) overexpression (IHC PR >10%)
PR>10%
Required: HER2 (ERBB2) wild-type (HER2 0 or +, if HER2++, FISH negative)
HER 0 OR +, if HER2++, FISH negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: CDK4/6 inhibitor
Exception: allowed if adjuvant CDK4/6 inhibitor therapy ended more than one year ago
without using adjuvant CDK4/6 inhibitors in the past, or one year after adjuvant CDK4/6 inhibitor therapy has ended
Cannot have received: chemotherapy
No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer
Cannot have received: targeted therapy
No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer
Cannot have received: radiotherapy
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.
Cannot have received: surgery
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.
Cannot have received: immunotherapy
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.
Lab requirements
Blood counts
HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×10^9/L; PLT≥75×10^9/L
Kidney function
Serum Cr ≤1.5×ULN, endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula)
Liver function
TBIL≤1.5×ULN; ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN
The functions of the main organs are basically normal, and the following conditions are met: Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×10^9/L; PLT≥75×10^9/L; Biochemical examination shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula);
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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