EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC)
Recruiting · NCT07646171 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Blood draw for biomarker and genetic analysisEverolimus (Afinitor) tablets with endocrine therapy
What this trial is about
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.
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- HR+MBC with PI3Kmut Post CDK 4/6+ET Post PI3K inhibitor+ET
Exclusion criteria
- Women who didn't receive anti-PI3K
Where it is running
1 location listed.
- Ichilov-Sourasky Medical Center - Tel Aviv, Israel