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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.

Plain-language title generated from the registry record
Registry title: EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC)

Key facts

Where
Tel Aviv, IsraelSee the site

Where in Israel

  • Ichilov-Sourasky Medical CenterTel Aviv, IsraelTaking people

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Trial details

Who runs it
Tel-Aviv Sourasky Medical Center
Trial code
NCT07646171
Record updated
12 June 2026
Original description
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.Read full original descriptionShow less

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.

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.

Inclusion: HR+MBC with PI3Kmut Post CDK 4/6+ET Post PI3K inhibitor+ET.

Exclusion: Women who didn't receive anti-PI3K.

ClinicalTrials.gov NCT07646171