NCT05949541 Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer
| NCT ID | NCT05949541 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 265 participants |
| Start Date | 2023-07-26 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 265 participants in total. It began in 2023-07-26 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Zhimin Shao, MD,PhD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT05949541 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05949541 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05949541 currently recruiting?
Yes, NCT05949541 is actively recruiting participants. Contact the research team at zhimingshao@yahoo.com for enrollment information.
Where is the NCT05949541 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05949541 clinical trial?
NCT05949541 is sponsored by Fudan University. The principal investigator is Zhimin Shao, MD,PhD at Fudan University. The trial plans to enroll 265 participants.
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