Recruiting
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer
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.
ClinicalTrials.gov IDNCT05949541
PhasePHASE2
Enrollment265
SponsorFudan University
Age18 Years – 75 Years
SexFEMALE
About this study
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.
Interventions
- Drug: Everolimus 10 mg — Everolimus is a kind of mTOR inhibitor which has been approved to use in several kinds of cancers, especially in metastatic breast cancer.
- Drug: CDK4/6 Inhibitor SHR6390 — Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.
- Drug: Aromatase inhibitor and Fulvestrant combined with CDK4/6 inhibitors — Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.
Primary outcomes
- Progression Free Survival (PFS) (Approximately 5 years)
Eligibility information
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 according to RECIST 1.1;
* The functions of the main organs are basically normal, and the following conditions are met:
1. Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L; PLT≥75×109/L;
2. 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);
* ECOG performance status 0 or 1; The expected survival is more than 3 months;
* Fertile female is required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug;
* Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up.
Exclusion Criteria:
* 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;
* Significant comorbid medical conditions, including mental illnesses that the investigator or sponsor believes would adversely affect the patient's participation in the study;
* Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
* The investigator does not consider the patient suitable for participation in any other circumstances of the study.
Study locations
- Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-19.