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

Recruiting

Conditions: 10003216
heart failure
left ventricular dysfunction
10019280

Registration Number: NL-OMON53099

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 628

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

- 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in (sub)clinical cardiovascular damage between patients treated<br /><br>with and without anthracyclines, as measured by left ventricular function<br /><br>parameters. </p><br>

Secondary Outcome Measures

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