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

NCT07646171 | Recruiting

• 1 other identifier: TLV-0295-21
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormone Receptor Positive Breast Cancer

Keywords

mTOR inhibitor; Hormone receptor positive breast cancer; PI3K inhibitor

Outcome Measures

Primary Outcomes (1)

• ORR

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

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

Secondary Outcomes (2)

• PFS

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

• CBR Clinical Benefit Rate

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

Study Arms (1)

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.

Drug: Everolimus (Afinitor) tablets with endocrine therapy; Procedure: Blood draw for biomarker and genetic analysis

Interventions

Blood draw for biomarker and genetic analysis PROCEDURE

"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."

HR+MBC post Alpelisib

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."

HR+MBC post Alpelisib

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Women who didn't receive anti-PI3K

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Ichilov-Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Interventions

Everolimus; Tablets; Blood Specimen Collection; Biomarkers; Genetic Testing

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Factors; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Central Study Contacts

Breast Cancer coordinator Breast Cancer coordinator

CONTACT

972-03-6974092; hananm@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 12, 2026
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)