A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer. (VERITAS)
29 de julio de 2026 actualizado por: AstraZeneca
VERITAS Longitudinal Real-world Registry of HR+/HER2- mBC to Understand Treatment Pattern and Clinical Outcomes in HR+/HER2- mBC
The study aims to describe demographics, clinical characteristics, genetic test diagnosis, treatment patterns, and clinical outcomes in HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer patients in China; and exploratory describe clinical outcomes by treatment regimens, also report the QoL and other patient-report outcomes (PRO) and to assess healthcare resource utilization (HCRU) and costs overall and by LoT.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
The study consists of both retrospective and prospective components, defined relative to the index date.
Tipo de estudio
De observación
Inscripción (Estimado)
2000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Astra Zeneca Clinical Study Information Center
- Número de teléfono: 1-877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Ubicaciones de estudio
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210029
- Reclutamiento
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
The study population includes Chinese adult patients with HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer who are about to initiate 2L systemic therapy or initiated 2L systemic therapy within 2 months at participating sites.
Descripción
Inclusion Criteria * Must be competent and able to comprehend, sign, and date an Institutional Review Board or Institutional Ethics Committee approved Informed consent form (ICF) before participating in the study.
OR Eligible for exemption from informed consent (for patients who die or became lost to follow-up within 2 months of initiating 2L therapy).
* Chinese men or women ≥ 18 years old at time of consent.
* Pathologically documented breast cancer that: a) is unresectable or metastatic.
b) is HR+/HER2- (IHC 2+/ISH- or IHC 1+ or IHC 0, with/without membrane staining) based on the most recent test result * Planning to initiate 2L treatment or initiated 2L systemic therapy within 2 months prior enrollment as per the prescription or medical records.
Exclusion Criteria * Patients who plan to participate in any blinded interventional clinical trial in 2L setting.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients with HR+/HER2- unresectable or metastatic breast cancer
The study will include adult patients with HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic breast cancer who plan to initiate second-line (2L) systemic therapy or initiated 2L systemic therapy within 2 months.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of patients receiving different regimens in each Line of treatment (LoT)
Periodo de tiempo: From baseline up to 5 years
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Percentage of participants receiving each systemic regimen within a given LoT.
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From baseline up to 5 years
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Percentage of participants receiving different treatment sequence across LoTs
Periodo de tiempo: From baseline up to 5 years
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Percentage of participants receiving different treatment sequence among those who entered the subsequent LoT.
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From baseline up to 5 years
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The attrition rate after each Line of Treatment (LoT)
Periodo de tiempo: From baseline up to 5 years
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Among participants with a documented therapy end for a given LoT, the percentage who did not initiate the next LoT.
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From baseline up to 5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Biomarker and Genetic Testing Pattern
Periodo de tiempo: From baseline up to 5 years
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Metrics include percentage of participants who undergo testing per biomarker/mutation within each LoT, testing timing, specimen type, assay method, and result distribution.
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From baseline up to 5 years
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Demographic characteristics
Periodo de tiempo: At baseline
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Metrics include descriptive statistics for age and counts for categorical variables
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At baseline
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Percentage of Participants with AEs, TRAEs, and SAEs
Periodo de tiempo: From baseline up to 5 years
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Proportion of participants with AEs, TRAEs, and SAEs, by MedDRA SOC/PT and CTCAE v6.0 grade; proportions with AEs leading to dose modification, discontinuation, or death.
Includes suspected drug, AE dates, seriousness, causality, and outcomes.
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From baseline up to 5 years
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Clinical management of adverse events of special interest
Periodo de tiempo: From baseline up to 5 years
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Metrics include percentage of participants who underwent diagnostic tests, prophylactic medications, therapeutic medications, dose modifications of treatment regimens, and follow-up assessments.
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From baseline up to 5 years
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Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Periodo de tiempo: At baseline
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Percentage of participants with different ECOG PS
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At baseline
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ER/PR status
Periodo de tiempo: At baseline
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Percentage of participants with different ER (estrogen receptor) and PR (progesterone receptor) status
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At baseline
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HER2 status
Periodo de tiempo: At baseline
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Percentage of participants with different HER2 (human epidermal growth factor receptor 2) status
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At baseline
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TNM stage at diagnosis
Periodo de tiempo: At baseline
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Percentage of participants with different Tumor (T), Node (N), Metastasis (M) stage at diagnosis
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At baseline
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Endocrine resistance
Periodo de tiempo: At baseline
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Percentage of participants with different endocrine resistance status
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At baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
5 de agosto de 2026
Finalización primaria (Estimado)
4 de agosto de 2031
Finalización del estudio (Estimado)
4 de agosto de 2031
Fechas de registro del estudio
Enviado por primera vez
10 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de julio de 2026
Publicado por primera vez (Actual)
4 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D3615R00009
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org.
All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Marco de tiempo para compartir IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Criterios de acceso compartido de IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .