Clinical trial · Observational
Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors
HARBOR Study: Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors
NCT02485626CI-TRIAL-00024516HARBORunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cardiovascular Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2D tissue doppler echocardiography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Anthracycline treated BC patients
- description
- 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.
- interventionNames
- Procedure: 2D tissue doppler echocardiography
- label
- Anthracycline naive BC patients
- description
- 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.
- interventionNames
- Procedure: 2D tissue doppler echocardiography
Primary outcomes (1)
- measure
- Left ventricular ejection fraction
- timeFrame
- up to 12 years after breast cancer diagnosis
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDvan Ommen-Nijhof A, Jacobse JN, Steggink LC, Lefrandt JD, Gietema JA, van Leeuwen FE, Schaapveld M, Sonke GS. Adjuvant aromatase inhibitor therapy and early markers for cardiovascular disease in breast cancer survivors. Breast Cancer Res Treat. 2022 Dec;196(3):591-602. doi: 10.1007/s10549-022-06714-0. Epub 2022 Oct 1. PMID 36181605