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Biology Guided Therapy Recommendations for Treatment Determination of Hormone Receptor-Positive Advanced, Unresectable or Metastatic Breast Cancer, ENDORSE Trial

12 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Duarte, California, Verenigde Staten, 91010
        • City of Hope Medical Center
        • Hoofdonderzoeker:
          • Irene M. Kang
        • Contact:
          • Irene M. Kang
          • Telefoonnummer: 844-756-2047
          • E-mail: ikang@coh.org
      • Irvine, California, Verenigde Staten, 92618
        • City of Hope at Irvine Lennar
        • Hoofdonderzoeker:
          • Irene M. Kang
        • Contact:
          • Irene M. Kang
          • Telefoonnummer: 844-756-2047
          • E-mail: ikang@coh.org

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: Magnetische resonantie beeldvorming
MRI ondergaan
Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Procedure: Biospecimen-collectie
Bloedafname ondergaan
Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
Procedure: Positronemissietomografie
PET-scan ondergaan
Andere namen:
  • Medische beeldvorming, positronemissietomografie
  • HUISDIER
  • PET-scan
  • Positron Emissie Tomografie Scan
  • Positron-emissietomografie
  • PT
  • Positronemissietomografie (procedure)
Procedure: Computertomografie
CT-scan ondergaan
Andere namen:
  • CT
  • KAT
  • CT-scan
  • Axiale computertomografie
  • Computergestuurde axiale tomografie
  • Computergestuurde tomografie
  • tomografie
  • Geautomatiseerde axiale tomografie (procedure)
  • Computertomografie (CT)-scan
  • Diagnostische kattencan
  • Diagnostisch CAT -scanservice type
Ander: Beoordeling van elektronische medische dossiers
Nevenstudies
Procedure: Botten scan
Onderga een botscan
Andere namen:
  • Botscintigrafie
Procedure: Biopsieprocedure
Onderga tumorbiopsie
Andere namen:
  • Bx
  • BIOSY_TYPE
  • Biopsie
Ander: Treatment Planning
Receive tumor biology report with predicted ongoing response
Ander: Treatment Regimen
Receive treatment recommendations
Andere namen:
  • Regimen
  • regimen or line of therapy
  • Regimen/Treatment Period/Vaccination Regimen
  • regimen_or_line_of_therapy
  • Treatment Protocol
  • Treatment Schedule

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Turnaround time (feasibility)
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Accrual rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

City of Hope Medical Center

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Irene M Kang, City of Hope Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

19 december 2026

Primaire voltooiing (Geschat)

2 december 2027

Studie voltooiing (Geschat)

2 december 2027

Studieregistratiedata

Eerst ingediend

4 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2026

Eerst geplaatst (Werkelijk)

15 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

12 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 24121 (Andere identificatie: City of Hope Comprehensive Cancer Center)
  • P30CA033572 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2026-02741 (Register-ID: CTRP (Clinical Trial Reporting Program))

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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