Breast Cancer Real-World Insights and Decision Guidance Evaluation in Hong Kong (BRIDGE-HK)
Breast Cancer Real-World Insights and Decision Guidance Evaluation (BRIDGE-HK) An Observational, Retrospective, Real-world Study on Breast Cancer Patients in Hong Kong Using the Hospital Authority CDARS Database
Breast cancer is the most common cancer affecting women in Hong Kong, but comprehensive real-world evidence on treatment and outcomes remains limited. This retrospective observational study will use Hong Kong Hospital Authority electronic health records, covering approximately 80% of healthcare utilisation, to evaluate around 45,000 adult women treated between 2018 and 2025. The study will describe patient characteristics, treatment patterns, treatment sequences, treatment duration, discontinuation, response, overall survival, and progression-free survival across HER2-positive, hormone receptor-positive/HER2-negative, and triple-negative subtypes. It will also assess neoadjuvant therapy, pathological complete response, and disease-free survival in eligible early-stage patients.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: AstraZeneca Clinical Study Information Center
- Número de telefone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Female breast cancer patients are anticipated, determined by data availability in the Hong Kong HA database (2018-2025).
Descrição
Inclusion Criteria:
- Female sex
- Age ≥18 years at the time of breast cancer diagnosis (index date)
- Histologically confirmed diagnosis of breast cancer (invasive or in situ) recorded in the HA database in all available records
- Documentation of surgery, or at least one systemic therapy (chemotherapy, endocrine therapy, targeted therapy, or immunotherapy) administered after the breast cancer diagnosis, as evidenced by pharmacy dispensing records or treatment administration records in the HA database between January 1, 2018, and December 31, 2025
- Availability of at least 6 months of follow-up data in the HA database after the index date, unless death occurs within the 6-month period
Exclusion Criteria:
- Male sex
- History of any other primary malignancy diagnosed prior to the index date (other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin) as identified through ICD-9-CM codes 140.x-172.x, 176.x-208.x (excluding 174.x) recorded in the HA database during the 120-month baseline lookback period
- Patients with documented participation in an interventional clinical trial during the study period, where such information is available in the HA database, to preserve the real-world representativeness of observed treatment patterns
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: RETROSPECTIVE
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sociodemographic Characteristics
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Age at diagnosis |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Sociodemographic Characteristics
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Ethnicity |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
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Clinical Characteristics
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Breast cancer subtype |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Clinical Characteristics
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Disease stage at diagnosis |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Clinical Characteristics
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Histological grade |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
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Clinical Characteristics
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Tumor size |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
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Clinical Characteristics
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Nodal status |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
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Clinical Characteristics
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
ECOG performance status |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
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Real-world treatment outcome
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
real-world overall survival |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Real-world treatment outcome
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Real-world progression-free survival |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
|
Real-world treatment outcome
Prazo: female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Treatment response status |
female breast cancer patients are anticipated, determined by data availability in database from 2018 to 2025
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Matthew Chiu, Clinical Assistant Professor, Department of Clinical Oncology, the University of Hong Kong
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D9673R00093
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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.
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 .