Biology Guided Therapy Recommendations for Treatment Determination of Hormone Receptor-Positive Advanced, Unresectable or Metastatic Breast Cancer, ENDORSE Trial
12 maggio 2026 aggiornato da: City of Hope Medical Center
Pilot Study: Evaluation of Novel Data-Driven Outcomes Via Response-Guided Systems Medicine in Hormone Receptor-Positive Advanced Breast Cancer (ENDORSE)
This clinical trial tests the feasibility and utility of a biology guided therapy recommendations report to aid in determining treatment of hormone receptor positive breast cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).
The biology guided therapy recommendations report is developed from testing a patients tumor tissue when they have progression to see what medications may work best and what medications the cancer may be resistant to based on their tumor biology.
Patients and their doctor then receive that report with the suggested treatments.
Receiving a biology guided therapy recommendations report may be a feasible and useable way to aid in treatment determination for hormone receptor positive advanced, unresectable or metastatic breast cancer.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
- Procedura: Risonanza magnetica
- Procedura: Raccolta di campioni biologici
- Procedura: Tomografia ad emissione di positroni
- Procedura: Tomografia computerizzata
- Altro: Revisione del Fascicolo Sanitario Elettronico
- Procedura: Scintigrafia ossea
- Procedura: Procedura di biopsia
- Altro: Treatment Planning
- Altro: Treatment Regimen
Descrizione dettagliata
PRIMARY OBJECTIVE:
I. To assess the feasibility and utility of using a systems medicine approach to evaluate tumor tissue from patients with hormone receptor-positive HER2-negative unresectable metastatic breast cancer after progression on first line therapy to both predict estrogen dependence and aid in selection of effective standard of care therapy.
SECONDARY OBJECTIVES:
I. To determine the accrual rate (AR). II. To measure the clinical benefit rate (CBR). III. To compare progression free survival (PFS) based on concordance with recommended treatment.
IV. To determine the duration of response (DoR). V. To measure the therapy acceptance rate (TAR).
EXPLORATORY OBJECTIVES:
I. To obtain additional genomic, epigenomic, and transcriptomic data on resistance mechanisms that informs future validation studies, artificial intelligence (AI) model-selected next line of therapy selection with anticipated highest efficacy amongst available options, and advanced AI model development.
II. To assess obstacles to enrollment and pitfalls of the study design to guide future studies.
OUTLINE:
Patients have their tumor tissue analyzed. Their physician receives a report based on their tumor biology consisting of their predicted ongoing response to endocrine therapy, predicted ongoing response to endocrine therapy plus PIK3CA mutation or ESR1 mutation or HER2 mutation or mTOR sensitivity/resistance. The report includes treatment recommendations and the results of the specific tests completed on the tumor tissue. Physicians then determine a treatment regimen for the patient that may or may not include the treatment recommended in the report. Patients undergo blood sample collection and computed tomography (CT) scan or magnetic resonance imaging (MRI) and/or bone scan and/or positron emission tomography (PET) scan throughout the study. Patients may undergo tumor biopsy during screening and may optionally undergo at progression.
After completion of study intervention, patients are followed every 3 months until disease progression.
Tipo di studio
Interventistico
Iscrizione (Stimato)
20
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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California
-
Duarte, California, Stati Uniti, 91010
- City of Hope Medical Center
-
Investigatore principale:
- Irene M. Kang
-
Contatto:
- Irene M. Kang
- Numero di telefono: 844-756-2047
- Email: ikang@coh.org
-
Irvine, California, Stati Uniti, 92618
- City of Hope at Irvine Lennar
-
Investigatore principale:
- Irene M. Kang
-
Contatto:
- Irene M. Kang
- Numero di telefono: 844-756-2047
- Email: ikang@coh.org
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Participant must speak English
Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
- Age: ≥ 18 years
- Patients must have histologically confirmed, unresectable or metastatic hormone receptor positive, HER2 breast cancer. Hormone receptor positive is defined as estrogen receptor >= 10% and/or progesterone receptor >= 10%. Her2 negative per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines
Patient must have disease progression during or after prior endocrine therapy meeting one of the following criteria:
- Disease progression on 1st line endocrine therapy for advanced/metastatic breast cancer.
- Disease progression on or within 2 years of completion of treatment with a CDK4/6i in the adjuvant setting for early- stage breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Patient must have at least one lesion amenable to percutaneous core
- Clinically appropriate for biopsy
Exclusion Criteria:
- Prior treatment in the metastatic setting with capecitabine, phosphoinositide 3 kinase (PI3K) inhibitor, mechanistic target of rapamycin (mTOR) inhibitor, protein kinase B (Akt) inhibitor, selective estrogen receptor degrader (SERD), or HER2-targeted therapy, including neratinib
- Known or untreated, or active, brain or leptomeningeal metastases that are deemed inappropriate to pursue therapy guided by systems medicine approach. Enrolled patients may receive radiation or other loco regional therapy prior to initiating systemic therapy on study. History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors not requiring active therapy
- Life expectancy < 1 year
- Pregnant or breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Treatment (Biology guided therapy report)
Patients have their tumor tissue analyzed.
Their physician receives a report based on their tumor biology consisting of their predicted ongoing response to endocrine therapy, predicted ongoing response to endocrine therapy plus PIK3CA mutation or ESR1 mutation or HER2 mutation or mTOR sensitivity/resistance.
The report includes treatment recommendations and the results of the specific tests completed on the tumor tissue.
Physicians then determine a treatment regimen for the patient that may or may not include the treatment recommended in the report.
Patients undergo blood sample collection and CT scan or MRI and/or bone scan and/or PET scan throughout the study.
Patients may undergo tumor biopsy during screening and may optionally undergo at progression.
|
Sottoponiti a risonanza magnetica
Altri nomi:
Sottoponiti al prelievo di campioni di sangue
Altri nomi:
Sottoponiti alla scansione PET
Altri nomi:
Sottoponiti a TAC
Altri nomi:
Studi accessori
Sottoponiti a scintigrafia ossea
Altri nomi:
Sotto la biopsia tumorale
Altri nomi:
Receive tumor biology report with predicted ongoing response
Receive treatment recommendations
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Turnaround time (feasibility)
Lasso di tempo: Up to 30 days.
|
Report consists of an Evaluation of Novel Data-driven Outcomes via Response-guided Systems Medicine in Hormone Receptor-positive Advanced Breast Cancer (ENDORSE) signature score, MTOR signature score and status of other Food and Drug Administration approved biomarkers, including ESR1 mutations, PIK3CA mutations and HER2 mutation/expression).
The turn-around time will be summarized by the range, mean, median, and standard deviation.
|
Up to 30 days.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Accrual rate
Lasso di tempo: Up to 1 year
|
Defined as is the number of patients enrolled over the period of a month.
|
Up to 1 year
|
|
Clinical benefit rate
Lasso di tempo: At 6 months
|
Will be summarized as the percentage of patients with complete response (CR), partial response (PR), or at least stable disease (SD) at 6 months.
|
At 6 months
|
|
Median progression free survival
Lasso di tempo: From study registration to progression, symptomatic deterioration, or death due to any cause, up to 1 year
|
From study registration to progression, symptomatic deterioration, or death due to any cause, up to 1 year
|
|
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Duration of overall response
Lasso di tempo: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, up to 1 year
|
From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, up to 1 year
|
|
|
Therapy acceptance rate
Lasso di tempo: Up to 1 year
|
Defined as the proportion of cases in which the recommended therapy by the study was the same as what was recommended by the physician.
|
Up to 1 year
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Irene M Kang, City of Hope Medical Center
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
19 dicembre 2026
Completamento primario (Stimato)
2 dicembre 2027
Completamento dello studio (Stimato)
2 dicembre 2027
Date di iscrizione allo studio
Primo inviato
4 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
12 maggio 2026
Primo Inserito (Effettivo)
15 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Qualità, accesso e valutazione dell'assistenza sanitaria
- Tecniche investigative
- Terapie
- Tecniche di laboratorio clinico
- Tecniche e procedure diagnostiche
- Diagnosi
- Procedure chirurgiche, operative
- Tecniche citologiche
- Citodiagnosi
- Meccanismi di valutazione dell'assistenza sanitaria
- Qualità dell'assistenza sanitaria
- Tecniche diagnostiche, chirurgiche
- Tecniche di chimica, analitiche
- Analisi dello spettro
- Caratteristiche di studio epidemiologico
- Biopsia
- Gestione dei campioni
- Spettroscopia di risonanza magnetica
- Protocolli clinici
Altri numeri di identificazione dello studio
- 24121 (Altro identificatore: City of Hope Comprehensive Cancer Center)
- P30CA033572 (Sovvenzione/contratto NIH degli Stati Uniti)
- NCI-2026-02741 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .