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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05949541 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify