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

28. oktober 2016 opdateret af: The Netherlands Cancer Institute

HARBOR Study: Identifying Subgroups With High Cardiovascular Risk in Breast Cancer Survivors

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

628

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
      • Amsterdam, Holland, 1066 CX
        • Rekruttering
        • NKI-AVL
      • Groningen, Holland, 9713 GZ
        • Rekruttering
        • UMCG

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
Andre navne:
  • genetisk analyse
  • livskvalitetsvurdering
  • laboratory biomarker analyses
  • vaskulær ultralyd
  • strain and strain rate parameters
  • spørgeskemaadministration
  • 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
Andre navne:
  • genetisk analyse
  • livskvalitetsvurdering
  • laboratory biomarker analyses
  • vaskulær ultralyd
  • strain and strain rate parameters
  • spørgeskemaadministration
  • anxiety and depression assessment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Left ventricular ejection fraction
Tidsramme: 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.
up to 12 years after breast cancer diagnosis

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diastolic cardiac function
Tidsramme: 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.
up to 12 years after breast cancer diagnosis
Cardiac deformation
Tidsramme: 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.
up to 12 years after breast cancer diagnosis
Biomarker assessment
Tidsramme: 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.
up to 12 years after breast cancer diagnosis
Intima media thickness and arterial stiffness
Tidsramme: 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.
up to 12 years after breast cancer diagnosis

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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.
up to 14 years after breast cancer diagnosis

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Netherlands Cancer Institute

Samarbejdspartnere

University Medical Center Groningen

Efterforskere

  • Ledende efterforsker: Flora E. van Leeuwen, Prof. dr., The Netherlands Cancer Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2015

Primær færdiggørelse (Forventet)

1. april 2019

Studieafslutning (Forventet)

1. december 2019

Datoer for studieregistrering

Først indsendt

23. juni 2015

Først indsendt, der opfyldte QC-kriterier

25. juni 2015

Først opslået (Skøn)

30. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NL49405.031.14

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