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

ConditionHormone Receptor Positive Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorTel-Aviv Sourasky Medical Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Women who didn't receive anti-PI3K

Trial population

HR+ MBC post CDK 4/6 inhibitors and anti PI3K inhibitor.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Everolimus (Afinitor) tablets with endocrine therapy

    Drug

    Patients receive standard of care treatment as prescribed by their treating physician. This study only observes the outcomes and does not alter the treatment regimen, dosing, or schedule."

  • Blood draw for biomarker and genetic analysis

    Procedure/Surgery

    "A supplementary blood sample is collected from participants to analyze genetic and molecular biomarkers, aiming to identify potential correlations between these markers and clinical response to the standard treatment."

Treatment groups

19 Participants
are divided into 1 treatment group
Group A: HR+MBC post Alpelisib2 interventions

Trial outcomes

Primary outcomes

1

ORR

Objective response rate -best response rate in the first scan 8-12 weeks from day1

Time frame
Response rate- From enrollment to the first scan at 8-12 weeks

Secondary outcomes

1

PFS

Time from Day 1 to progression, an average of 16 weeks

Time frame
From date of enrollment until the date of first documented progression, assessed up to 24 months.
2

CBR Clinical Benefit Rate

Proportion with CR/PR or stable disease ≥24 weeks

Time frame
Through the end of the study, assessed up to 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tel-Aviv Sourasky Medical Center

Lead sponsor

Source ClinicalTrials.gov
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