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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.

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.

2D tissue doppler echocardiography

Flora E. van Leeuwen, Prof. dr.

Jourik A. Gietema, Prof. dr.

The purpose of this study is to evaluate the prevalence of (sub)clinical cardiovascular disease, cardiovascular risk factors and metabolic abnormalities among long-term breast cancer survivors treated with or without anthracyclines in order to identify patients at increased risk of developing cardiovascular disease.

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.

Consent is obtained from participants to draw blood for DNA-analyses to evaluate whether specific genes modify the risk of treatment-induced cardiovascular disease.

Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors

HARBOR Study: Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors

To compare each outcome of the first and second assessment separately in 1) every patient and 2) between patients treated with and without anthracyclines.

The main study parameter will be the difference in left ventricular ejection fraction between patients treated with and without anthracyclines.

To compare diastolic cardiac function as measured by tissue doppler echocardiography (E/e' and E/A ratio) in patients treated with and without anthracyclines.

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.

To compare levels of several (candidate) cardiovascular biomarkers (NT-proBNP, hs-TnT, CRP) in patients treated with and without anthracyclines.

To compare intima media thcikness and arterial stiffness as measured by vascular ultrasound in patients treated with and without anthracyclines.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors	NCT02485626	Breast Neoplasm... Cardiovascular ...	2D tissue doppl...	40 Years - 50 Years	The Netherlands Cancer Institute
Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors	NCT02485626	Breast Neoplasm... Cardiovascular ...	2D tissue doppl...	40 Years - 50 Years	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for 2d tissue doppler echocardiography