Everolimus with hormone therapy after alpelisib in women with advanced hormone receptor-positive breast cancer
Tests everolimus plus hormone therapy in women whose breast cancer progressed on a PI3K inhibitor.
Key facts
- Who runs it
- Tel-Aviv Sourasky Medical Center
- Where
- Tel Aviv, IsraelSee the site
- Trial code
- Registry title
- EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC)
- Status
- Recruiting
- People taking part
- 19 people, planned
- Started
- 1 Sept 2022
- Expected to end
- 31 Dec 2027
- Type of study
- Observational
- Treatments tested
- Everolimus (Afinitor) tablets with endocrine therapy
- Blood draw for biomarker and genetic analysis
- Record updated
- 12 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with hormone receptor-positive breast cancer that has spread and whose cancer grew after a PI3K inhibitor with endocrine therapy.
- Age
- 21 Years or older
- Sex
- All sexes can join. The trial title names women.
- Disease stage
- Hormone receptor-positive (HR+) metastatic breast cancer.
- Earlier treatment
- Must have had a CDK 4/6 inhibitor with endocrine therapy, and then a PI3K inhibitor with endocrine therapy. Women who did not receive an anti-PI3K drug cannot join.
- Biomarker or test result
- The cancer must have a PI3K gene change (PI3Kmut).
Main reasons for not taking part
- Women who did not receive an anti-PI3K drug
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- HR+MBC with PI3Kmut Post CDK 4/6+ET Post PI3K inhibitor+ET
Who cannot take part
- Women who didn't receive anti-PI3K
Where in Israel
- Ichilov-Sourasky Medical CenterTel Aviv, IsraelContact: Hanan Mansour Breast cancer study coordinatorTaking people
About the trial
What the trial wants to find out
This phase II, open-label, single-arm, study investigates the clinical benefit of everolimus combined with endocrine therapy (ET) in hormone receptor-positive (HR+), metastatic breast cancer (MBC) patients who progressed on prior PI3K inhibitor therapy (+ ET). 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.
The group in the trial
- HR+MBC post Alpelisib
Patients with HR+MBC post Alpelisib treatment who are scheduled to receive Everolimus with endocrine therapy, an additional blood sample is collected for biomarker evaluation.
Treatment: Everolimus (Afinitor) tablets with endocrine therapy and Blood draw for biomarker and genetic analysis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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.
- Plain-language title
- Everolimus with hormone therapy after alpelisib in women with advanced hormone receptor-positive breast cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 12 June 2026