EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC) (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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Detailed Description The study employs a two-stage design to evaluate the primary endpoint of clinical response rate (complete/partial response per RECIST v1.1). Stage 1 will enroll 19 patients with measurable disease; if no responses are observed, the trial terminates. If ≥1 response occurs, 24 additional patients will be enrolled (total N=43), with success defined as ≥2 responses. Secondary endpoints include progression-free survival (PFS), clinical benefit rate (CBR), and biomarker analysis via longitudinal ctDNA profiling to identify genomic drivers of resistance/sensitivity. Eligible participants receive everolimus (10 mg/day) + ET until progression, unacceptable toxicity, or withdrawal. Tumor assessments occur every 8 weeks, with toxicity monitoring.
Study Design
Intervention Model: Single-group assignment
Primary Purpose: Treatment
Phase: II
Allocation: Non-randomized
Masking: None (open-label)
Outcome Measures
Primary: Objective response rate (ORR).
Secondary:
PFS (time from treatment initiation to progression/death).
CBR (proportion with CR/PR or stable disease ≥24 weeks).
Biomarker correlation (e.g., ESR1 mutations, PTEN alterations) via ctDNA analysis.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Breast Cancer coordinator Breast Cancer coordinator
- Telefonnummer: 972-03-6974092
- E-post: hananm@tlvmc.gov.il
Studieorter
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Tel Aviv, Israel
- Rekrytering
- Ichilov-Sourasky Medical Center
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Kontakt:
- Hanan Mansour Breast cancer study coordinator
- Telefonnummer: 97236974062
- E-post: hananm@tlvmc.gov.il
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- HR+MBC with PI3Kmut Post CDK 4/6+ET Post PI3K inhibitor+ET
Exclusion Criteria:
- Women who didn't receive anti-PI3K
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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.
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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."
"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."
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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ORR
Tidsram: Response rate- From enrollment to the first scan at 8-12 weeks
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Objective response rate -best response rate in the first scan 8-12 weeks from day1
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Response rate- From enrollment to the first scan at 8-12 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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PFS
Tidsram: From date of enrollment until the date of first documented progression, assessed up to 24 months.
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Time from Day 1 to progression, an average of 16 weeks
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From date of enrollment until the date of first documented progression, assessed up to 24 months.
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CBR Clinical Benefit Rate
Tidsram: Through the end of the study, assessed up to 24 months.
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Proportion with CR/PR or stable disease ≥24 weeks
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Through the end of the study, assessed up to 24 months.
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Organiska kemikalier
- Farmaceutiska förberedelser
- Undersökningstekniker
- Doseringsformer
- Provhantering
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Punktering
- Kirurgiska ingrepp, operativ
- Biologiska faktorer
- Vårdtjänster
- Sjukvårdsanläggningar och tjänster
- Förebyggande hälsovårdstjänster
- Makrolider
- Laktoner
- Sirolimus
- Genetiska tekniker
- Genetiska tjänster
- Diagnostiska tjänster
- Everolimus
- Tabletter
- Genetisk testning
- Blodprovsamling
- Biomarkörer
Andra studie-ID-nummer
- TLV-0295-21
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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