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Identifying subgroups with High cArdiovascular Risk in Breast cancer survivORs (HARBOR)

Identifying subgroups with High cArdiovascular Risk in Breast cancer survivORs (HARBOR) - HARBOR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53099
Enrollment
628
Registered
2014-12-08
Start date
2015-02-20
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure left ventricular dysfunction

Interventions

None listed

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - female; - 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

Exclusion criteria: - history of RT or CT unrelated to BC; - currently under treatment for BC recurrence or second malignancy (including contralateral BC) other than non-melanomatous 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.

Design outcomes

Primary

MeasureTime frame
The difference in (sub)clinical cardiovascular damage between patients treated with and without anthracyclines, as measured by left ventricular function parameters.

Secondary

MeasureTime frame
Secondary parameters are the difference in the prevalence of cardiovascular risk factors, the difference of biochemical measurements related to cardiovascular risk and function, the difference in reproductive history and menopausal status, the difference in quality of life, anxiety, depression and fatigue, the difference in cardiovascular function tests, the difference in physical activity, the difference in cognitive functioning, the difference in presence of cellular senescence and the difference in DNA profiles and telomere length between patients treated with and without anthracyclines.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)