Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors (HARBOR)
HARBOR Study: Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Rationale: Breast cancer (BC) incidence is increasing, while mortality from BC is decreasing. Since the life expectancy of BC patients is improving, the evaluation of treatment-associated cardiovascular disease (CVD) in BC survivors is becoming increasingly important. An excess risk of CVD, mainly due to coronary heart disease (CHD), has been observed after radiotherapy (RT) as administered in the 1960s-1980s. Anthracycline-containing CT and trastuzumab are known to induce cardiotoxicity, especially congestive heart failure (CHF). However, the long-term risks of CVD after anthracycline-containing CT, trastuzumab, hormonal therapy (HT) and contemporary RT techniques have hardly been examined. Furthermore, the potential interaction of these treatment modalities has not been well addressed, and there is limited knowledge about the contribution of classic cardiovascular risk factors and the metabolic syndrome to risk and severity of treatment-associated CVD in BC survivors.
Objectives: • to evaluate the prevalence of (sub)clinical CVD, cardiovascular risk factors and metabolic abnormalities among BC survivors treated with and without anthracyclines in two groups at (a) 5 - 7 years and (b) 10 - 12 years after diagnosis;
• to prospectively evaluate changes in prevalence of (sub)clinical CVD, cardiovascular risk factors and metabolic abnormalities after two years in the same patients.
Secondary objectives are to evaluate the predictive role of newly developed markers for CVD and to evaluate the effects of other BC treatment modalities, psychosocial outcomes, endocrine function and menopausal status on the risk of developing (sub)clinical CVD.
Study design: multicenter (AVL and UMCG) cross-sectional cohort study with prospective monitoring of the same cohort.
Study population: female BC survivors treated with and without anthracyclines 5 - 7 and 10 - 12 years ago at the AVL or UMCG, aged 40-50 years at time of therapy.
Main study parameter: the difference in (sub)clinical cardiovascular damage between patients treated with and without anthracyclines, as measured by left ventricular function parameters.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Amsterdam, Países Bajos, 1066 CX
- Reclutamiento
- NKI-AVL
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Groningen, Países Bajos, 9713 GZ
- Reclutamiento
- UMCG
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- early invasive BC (TNM stage I - III);
- diagnosed and/or treated in the AVL or UMCG;
- treated 5 - 7 years or 10 - 12 years ago;
- aged 40-50 years at time of therapy;
- signed written informed consent.
Exclusion Criteria:
- history of RT or CT unrelated to BC;
- current treatment for BC recurrence or second malignancy (including contralateral BC) with the exception of non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix;
- history of cardiac disease (CHF, acute coronary syndrome, coronary revascularization procedure, symptomatic valvular dysfunction, cardiomyopathy or congenital heart defect) before diagnosis and treatment for BC;
- mental disability or psychological condition potentially hampering compliance with the study protocol;
- insufficient understanding of the Dutch language.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Anthracycline treated BC patients
AVL or UMCG patients between the age of 40 - 50 at the time of BC diagnosis and treatment, treated with anthracyclines respectively 5-7 years ago and 10-12 years ago.
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Otros nombres:
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Anthracycline naive BC patients
AVL or UMCG patients between the age of 40 - 50 at the time of BC diagnosis and treatment, treated without anthracyclines respectively 5-7 years ago and 10-12 years ago.
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Left ventricular ejection fraction
Periodo de tiempo: up to 12 years after breast cancer diagnosis
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The main study parameter will be the difference in left ventricular ejection fraction between patients treated with and without anthracyclines.
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up to 12 years after breast cancer diagnosis
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diastolic cardiac function
Periodo de tiempo: up to 12 years after breast cancer diagnosis
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To compare diastolic cardiac function as measured by tissue doppler echocardiography (E/e' and E/A ratio) in patients treated with and without anthracyclines.
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up to 12 years after breast cancer diagnosis
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Cardiac deformation
Periodo de tiempo: up to 12 years after breast cancer diagnosis
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To compare cardiac deformation as measured by speckle tracking imaging (global longitudial strain, radial strain and circumferential strain) in patients treated with and without anthracyclines.
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up to 12 years after breast cancer diagnosis
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Biomarker assessment
Periodo de tiempo: up to 12 years after breast cancer diagnosis
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To compare levels of several (candidate) cardiovascular biomarkers (NT-proBNP, hs-TnT, CRP) in patients treated with and without anthracyclines.
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up to 12 years after breast cancer diagnosis
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Intima media thickness and arterial stiffness
Periodo de tiempo: up to 12 years after breast cancer diagnosis
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To compare intima media thcikness and arterial stiffness as measured by vascular ultrasound in patients treated with and without anthracyclines.
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up to 12 years after breast cancer diagnosis
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prospective evaluation of changes in LVEF, diastolic cardiac function, cardiac deformation, biomarkers levels, intima media thickness and arterial stiffness after two years in the same patients.
Periodo de tiempo: up to 14 years after breast cancer diagnosis
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To compare each outcome of the first and second assessment separately in 1) every patient and 2) between patients treated with and without anthracyclines.
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up to 14 years after breast cancer diagnosis
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Flora E. van Leeuwen, Prof. dr., The Netherlands Cancer Institute
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NL49405.031.14
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