Biology Guided Therapy Recommendations for Treatment Determination of Hormone Receptor-Positive Advanced, Unresectable or Metastatic Breast Cancer, ENDORSE Trial
12 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
- Procédure: Imagerie par résonance magnétique
- Procédure: Collecte d'échantillons biologiques
- Procédure: Tomographie par émission de positrons
- Procédure: Tomodensitométrie
- Autre: Examen du dossier de santé électronique
- Procédure: Scanner osseux
- Procédure: Procédure de biopsie
- Autre: Treatment Planning
- Autre: Treatment Regimen
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
Duarte, California, États-Unis, 91010
- City of Hope Medical Center
-
Chercheur principal:
- Irene M. Kang
-
Contact:
- Irene M. Kang
- Numéro de téléphone: 844-756-2047
- E-mail: ikang@coh.org
-
Irvine, California, États-Unis, 92618
- City of Hope at Irvine Lennar
-
Chercheur principal:
- Irene M. Kang
-
Contact:
- Irene M. Kang
- Numéro de téléphone: 844-756-2047
- E-mail: ikang@coh.org
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Passer une IRM
Autres noms:
Subir une collecte d'échantillons de sang
Autres noms:
Passer un PET scan
Autres noms:
Passer un scanner
Autres noms:
Etudes annexes
Passer une scintigraphie osseuse
Autres noms:
Subir une biopsie tumorale
Autres noms:
Receive tumor biology report with predicted ongoing response
Receive treatment recommendations
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Turnaround time (feasibility)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Accrual rate
Délai: 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
Délai: 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
Délai: 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
|
|
|
Duration of overall response
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Irene M Kang, City of Hope Medical Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
19 décembre 2026
Achèvement primaire (Estimé)
2 décembre 2027
Achèvement de l'étude (Estimé)
2 décembre 2027
Dates d'inscription aux études
Première soumission
4 mai 2026
Première soumission répondant aux critères de contrôle qualité
12 mai 2026
Première publication (Réel)
15 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Qualité des soins de santé, accès et évaluation
- Techniques d'investigation
- Thérapeutique
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Procédures chirurgicales, opératoires
- Techniques cytologiques
- Cytodiagnostic
- Mécanismes d'évaluation des soins de santé
- Qualité des soins de santé
- Techniques de diagnostic, chirurgicale
- Techniques de chimie, analytique
- Analyse du spectre
- Caractéristiques de l'étude épidémiologique
- Biopsie
- Manipulation des échantillons
- Spectroscopie de résonance magnétique
- Protocoles cliniques
Autres numéros d'identification d'étude
- 24121 (Autre identifiant: City of Hope Comprehensive Cancer Center)
- P30CA033572 (Subvention/contrat des NIH des États-Unis)
- NCI-2026-02741 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .