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

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

Qualifiers

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

Disqualifiers

Women who didn't receive anti-PI3K

Trial design

Treatments tested in this trial

  • Everolimus (Afinitor) tablets with endocrine therapy
  • Blood draw for biomarker and genetic analysis

Treatment groups

19 Participants
are divided into 1 treatment group