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Recruiting NCT07646171

NCT07646171 EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC)

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Clinical Trial Summary
NCT ID NCT07646171
Status Recruiting
Phase
Sponsor Tel-Aviv Sourasky Medical Center
Condition Hormone Receptor Positive Breast Cancer
Study Type OBSERVATIONAL
Enrollment 19 participants
Start Date 2022-09-01
Primary Completion 2026-12-31

Eligibility & Interventions

Sex All sexes
Min Age 21 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Everolimus (Afinitor) tablets with endocrine therapyBlood draw for biomarker and genetic analysis

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 19 participants in total. It began in 2022-09-01 with a primary completion date of 2026-12-31.

⚠ 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 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.

Eligibility 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

Contact & Investigator

Central Contact

Breast Cancer coordinator Breast Cancer coordinator

✉ hananm@tlvmc.gov.il

📞 972-03-6974092

Frequently Asked Questions

Who can join the NCT07646171 clinical trial?

This trial is open to participants of all sexes, aged 21 Years or older, studying Hormone Receptor Positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07646171 currently recruiting?

Yes, NCT07646171 is actively recruiting participants. Contact the research team at hananm@tlvmc.gov.il for enrollment information.

Where is the NCT07646171 trial being conducted?

This trial is being conducted at Tel Aviv, Israel.

Who is sponsoring the NCT07646171 clinical trial?

NCT07646171 is sponsored by Tel-Aviv Sourasky Medical Center. The trial plans to enroll 19 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology