Clinical trial · Observational
EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC)
EVERST- Everolimus After Alpelisib in Women With HR+ MBC- This Phase II, Open-label, Single-arm, Study Investigates the Clinical Benefit of Everolimus Combined With Endocrine Therapy. in Hormone Receptor-positive (HR+), Metastatic Breast Cancer Patients Who Progressed on Prior PI3K Inhibitor Therapy With Endocrine Therapy. 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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw for biomarker and genetic analysis | Procedure | — | UNRESOLVED |
| Everolimus (Afinitor) tablets with endocrine therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HR+MBC post Alpelisib
- description
- 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.
- interventionNames
- Drug: Everolimus (Afinitor) tablets with endocrine therapy
- Procedure: Blood draw for biomarker and genetic analysis
Primary outcomes (1)
- measure
- ORR
- timeFrame
- Response rate- From enrollment to the first scan at 8-12 weeks
- description
- Objective response rate -best response rate in the first scan 8-12 weeks from day1
Secondary outcomes (2)
- measure
- PFS
- timeFrame
- From date of enrollment until the date of first documented progression, assessed up to 24 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * HR+MBC with PI3Kmut Post CDK 4/6+ET Post PI3K inhibitor+ET Exclusion Criteria: * Women who didn't receive anti-PI3K
References
Publications (0)
Data not yet available