NCT02485626

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
628

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

June 23, 2015

Last Update Submit

October 28, 2016

Conditions

Breast NeoplasmsCardiovascular Diseases

Keywords

Anthracyclines

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction

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

    up to 12 years after breast cancer diagnosis

Secondary Outcomes (4)

  • Diastolic cardiac function

    up to 12 years after breast cancer diagnosis

  • Cardiac deformation

    up to 12 years after breast cancer diagnosis

  • Biomarker assessment

    up to 12 years after breast cancer diagnosis

  • Intima media thickness and arterial stiffness

    up to 12 years after breast cancer diagnosis

Other Outcomes (1)

  • 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.

    up to 14 years after breast cancer diagnosis

Study Arms (2)

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.

Procedure: 2D tissue doppler echocardiography

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.

Procedure: 2D tissue doppler echocardiography

Interventions

2D tissue doppler echocardiographyPROCEDURE
Also known as: laboratory biomarker analyses, vascular ultrasound, strain and strain rate parameters, genetic analysis, questionnaire administration, quality of life assessment, anxiety and depression assessment
Anthracycline naive BC patientsAnthracycline treated BC patients

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants will be recruited from a large retrospective cohort of BC patients.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NKI-AVL

Amsterdam, 1066 CX, Netherlands

RECRUITING

UMCG

Groningen, 9713 GZ, Netherlands

RECRUITING

Related Publications (1)

  • van 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: 36181605DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Breast NeoplasmsCardiovascular Diseases

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Flora E. van Leeuwen, Prof. dr.

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Flora E. van Leeuwen, Prof. dr.

CONTACT

f.v.leeuwen@nki.nl

Jourik A. Gietema, Prof. dr.

CONTACT

j.a.gietema@umcg.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 30, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2019

Study Completion

December 1, 2019

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

NL(2)