Everolimus After Alpelisib in HR+ Metastatic Breast Cancer
Official title: EVERST- Everolimus After Alpelisib in Women With HR+ MBC- This Phase II, Open-label, Single-arm, Study Investigates the Clinical Benefit of Everolimus Combined With Endocrine Therapy. in Hormone Receptor-positive (HR+), Metastatic Breast Cancer Patients Who Progressed on Prior PI3K Inhibitor Therapy With Endocrine Therapy. The Trial Aims to Determine if Sequential Inhibition of the PI3K/AKT/mTORC1 Pathway Retains Efficacy Post-PI3K Inhibitor Resistance, Hypothesizing That Everolimus Will Demonstrate a Response Rate Exceeding the Historical 9.5% Observed in the BOLERO2 Trial.
Run by Tel-Aviv Sourasky Medical Center · NCT07646171 · Data updated 2026-11-12
This study tests whether adding everolimus to endocrine therapy can help HR+ metastatic breast cancer patients who progressed on a PI3K inhibitor see a benefit.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 19 (estimated) |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 1 site (Tel Aviv) |
| Status | Recruiting |
| Started | September 1, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT07646171 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are HR+ metastatic breast cancer patients who progressed on a PI3K inhibitor and are suitable for daily everolimus plus ongoing endocrine therapy.
✕Probably not a fit
Patients whose tumors do not respond to mTOR inhibition or who experience intolerable toxicity from everolimus may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase II, open-label, single-arm trial evaluating everolimus combined with endocrine therapy in HR+ metastatic breast cancer after progression on a PI3K inhibitor. The study uses a two-stage design: if no responses occur in stage 1 (n=19), the trial stops; if at least one response is observed, enrollment continues to a total of 43 patients with a goal of at least two responses. Primary endpoint is objective response rate by RECIST v1.1, with secondary endpoints including progression-free survival, clinical benefit rate, and biomarker analysis through longitudinal ctDNA profiling to identify resistance and sensitivity drivers. Participants receive everolimus 10 mg daily plus endocrine therapy until progression, intolerable toxicity, or withdrawal, with tumor assessments every 8 weeks.
Why it matters
Potential benefit: If successful, patients may experience tumor shrinkage or disease control and potentially longer progression-free survival with this combination after PI3K inhibitor therapy.
How similar studies have gone: Prior trials targeting the PI3K/AKT/mTOR pathway have shown activity in HR+ MBC, but this specific sequential inhibition approach after PI3K inhibitor failure is exploratory and built on limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * HR+MBC with PI3Kmut Post CDK 4/6+ET Post PI3K inhibitor+ET Exclusion Criteria: * Women who didn't receive anti-PI3K
Where it's running
-
Ichilov-Sourasky Medical Center
Tel Aviv, Israel Recruiting
Study contacts
- Study coordinator: Breast Cancer coordinator Breast Cancer coordinator
- Email: hananm@tlvmc.gov.il
- Phone: 972-03-6974092
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.