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

RECRUITINGSponsored by Tel-Aviv Sourasky Medical Center
Actively Recruiting
SponsorTel-Aviv Sourasky Medical Center
Started2022-09-01
Est. completion2026-12-31
Eligibility
Age21 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07646171

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

Age: 21 Years+Healthy volunteers accepted
Inclusion Criteria:

* HR+MBC with PI3Kmut Post CDK 4/6+ET Post PI3K inhibitor+ET

Exclusion Criteria:

* Women who didn't receive anti-PI3K

Conditions3

Breast CancerCancerHormone Receptor Positive Breast Cancer

Interventions1

Everolimus (Afinitor) tablets with endocrine therapy

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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