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Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors (HARBOR)

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ClinicalTrials.gov Identifier: NCT02485626
Recruitment Status : Unknown
Verified October 2016 by The Netherlands Cancer Institute.
Recruitment status was:  Recruiting
First Posted : June 30, 2015
Last Update Posted : October 31, 2016
Sponsor:
Collaborator:
University Medical Center Groningen
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment
Breast Neoplasms Cardiovascular Diseases Procedure: 2D tissue doppler echocardiography

Detailed Description:

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 628 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: HARBOR Study: Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors
Study Start Date : April 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Other Names:
  • 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 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
Other Names:
  • laboratory biomarker analyses
  • vascular ultrasound
  • strain and strain rate parameters
  • genetic analysis
  • questionnaire administration
  • quality of life assessment
  • anxiety and depression assessment


Outcome Measures
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Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: up to 12 years after breast cancer diagnosis ]
    The main study parameter will be the difference in left ventricular ejection fraction between patients treated with and without anthracyclines.


Secondary Outcome Measures :
  1. Diastolic cardiac function [ Time Frame: up to 12 years after breast cancer diagnosis ]
    To compare diastolic cardiac function as measured by tissue doppler echocardiography (E/e' and E/A ratio) in patients treated with and without anthracyclines.

  2. Cardiac deformation [ Time Frame: up to 12 years after breast cancer diagnosis ]
    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.

  3. Biomarker assessment [ Time Frame: up to 12 years after breast cancer diagnosis ]
    To compare levels of several (candidate) cardiovascular biomarkers (NT-proBNP, hs-TnT, CRP) in patients treated with and without anthracyclines.

  4. Intima media thickness and arterial stiffness [ Time Frame: up to 12 years after breast cancer diagnosis ]
    To compare intima media thcikness and arterial stiffness as measured by vascular ultrasound in patients treated with and without anthracyclines.


Other Outcome Measures:
  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. [ Time Frame: up to 14 years after breast cancer diagnosis ]
    To compare each outcome of the first and second assessment separately in 1) every patient and 2) between patients treated with and without anthracyclines.


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.

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants will be recruited from a large retrospective cohort of BC patients.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485626


Contacts
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Contact: Flora E. van Leeuwen, Prof. dr. f.v.leeuwen@nki.nl
Contact: Jourik A. Gietema, Prof. dr. j.a.gietema@umcg.nl

Locations
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Netherlands
NKI-AVL Recruiting
Amsterdam, Netherlands, 1066 CX
UMCG Recruiting
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
The Netherlands Cancer Institute
University Medical Center Groningen
Investigators
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Principal Investigator: Flora E. van Leeuwen, Prof. dr. The Netherlands Cancer Institute
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02485626    
Other Study ID Numbers: NL49405.031.14
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Keywords provided by The Netherlands Cancer Institute:
Anthracyclines
Additional relevant MeSH terms:
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Breast Neoplasms
Cardiovascular Diseases
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases