Biology Guided Therapy Recommendations for Treatment Determination of Hormone Receptor-Positive Advanced, Unresectable or Metastatic Breast Cancer, ENDORSE Trial
12 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
- Procedimento: Imagem de ressonância magnética
- Procedimento: Coleta de bioespécimes
- Procedimento: Tomografia por emissão de pósitrons
- Procedimento: Tomografia Computadorizada
- Outro: Revisão do Registro Eletrônico de Saúde
- Procedimento: Cintilografia óssea
- Procedimento: Procedimento de biópsia
- Outro: Treatment Planning
- Outro: Treatment Regimen
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Estimado)
20
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
California
-
Duarte, California, Estados Unidos, 91010
- City of Hope Medical Center
-
Investigador principal:
- Irene M. Kang
-
Contato:
- Irene M. Kang
- Número de telefone: 844-756-2047
- E-mail: ikang@coh.org
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Irvine, California, Estados Unidos, 92618
- City of Hope at Irvine Lennar
-
Investigador principal:
- Irene M. Kang
-
Contato:
- Irene M. Kang
- Número de telefone: 844-756-2047
- E-mail: ikang@coh.org
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
Submeter-se a ressonância magnética
Outros nomes:
Realizar coleta de sangue
Outros nomes:
Fazer PET scan
Outros nomes:
Fazer tomografia computadorizada
Outros nomes:
Estudos auxiliares
Fazer varredura óssea
Outros nomes:
Sofre biópsia tumoral
Outros nomes:
Receive tumor biology report with predicted ongoing response
Receive treatment recommendations
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Turnaround time (feasibility)
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Accrual rate
Prazo: Up to 1 year
|
Defined as is the number of patients enrolled over the period of a month.
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Up to 1 year
|
|
Clinical benefit rate
Prazo: 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
Prazo: 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
Prazo: 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
|
|
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Therapy acceptance rate
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Irene M Kang, City of Hope Medical Center
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
19 de dezembro de 2026
Conclusão Primária (Estimado)
2 de dezembro de 2027
Conclusão do estudo (Estimado)
2 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
4 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de maio de 2026
Primeira postagem (Real)
15 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Qualidade, acesso e avaliação da assistência médica
- Técnicas de investigação
- Terapêutica
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Procedimentos cirúrgicos, operatórios
- Técnicas citológicas
- Citodiagnóstico
- Mecanismos de avaliação de saúde
- Qualidade de assistência médica
- Técnicas de diagnóstico, cirúrgico
- Técnicas de química, analíticas
- Análise de espectro
- Características do estudo epidemiológico
- Biópsia
- Manipulação de amostras
- Espectroscopia de ressonância magnética
- Protocolos clínicos
Outros números de identificação do estudo
- 24121 (Outro identificador: City of Hope Comprehensive Cancer Center)
- P30CA033572 (Concessão/Contrato do NIH dos EUA)
- NCI-2026-02741 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .