NCT02541435

Brief Summary

In Europe, breast cancer is by far the most common form of cancer diagnosed in women today, accounting for 29% of all cases. The 5-year survival rate is approximately 90%. Surgery is usually combined with radiotherapy (RT), anthracyclines, aromatase inhibitors and/or trastuzumab (Herceptin) which all have improved the life expectancy and survival in breast cancer patients. Unfortunately, RT is associated with a broad spectrum of cardiovascular diseases, which includes coronary artery disease, valvular dysfunction, congestive heart failure and stroke, and is the most common non-malignancy cause of death. During the last two decades, RT regimens for breast cancer have changed and the doses of radiation to which the heart is exposed are now potentially lower due to new and improved RT techniques. However, there are no data on whether these new regimes decrease the risk of cardiovascular disease. In this study the incidence and prevalence of cardiovascular diseases will be estimated 8 and 15 years after both conventional and laser assisted breath controlled RT, and compared with cardiovascular diseases in the general female population. A further aim is to evaluate signs and prevalence of acute cardiotoxicity from RT with the use of cardiac magnetic resonance imaging, coronary fractional flow reserve, ECG and inflammatory and cardiac biomarkers and to investigate whether these signs can predict later cardiovascular disease. The importance of traditional cardiovascular risk factors (age, hypertension, hypercholesterolemia, smoking habits and physical activity, as registered before RT) will also be evaluated.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
128mo left

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress48%
Nov 2016Dec 2036

First Submitted

Initial submission to the registry

September 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2036

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

13.1 years

First QC Date

September 1, 2015

Last Update Submit

June 2, 2026

Conditions

Breast NeoplasmsCardiovascular Diseases

Keywords

RadiotherapyBiological markersMagnetic resonance imagingEchocardiographyTomography, X-Ray ComputedRisk factorsHeartQuality of Life

Outcome Measures

Primary Outcomes (2)

  • incidence of cardiovascular disease

    compared with corresponding estimates from the female general population (HUNT-registry data, age-matched sample)

    8 years

  • incidence of cardiovascular disease

    compared with corresponding estimates from the female general population (HUNT-registry data, age-matched sample)

    15 years

Study Arms (3)

conventional radiotherapy

450 breast cancer patients treated with conventional radiotherapy with or without anthracyclines and/or trastuzumab during 2007-2012

breath controlled radiotherapy

350 breast cancer patients treated with laser assisted breath controlled radiotherapy with or without anthracyclines and/or trastuzumab during 2015-2017

controls

per participating patient 2 age-matched female controls from the HUNT-3 population (total 800)

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women treated for breast cancer with radiotherapy

You may qualify if:

  • diagnosis of breast cancer
  • expected life-expectancy above 10 years

You may not qualify if:

  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ålesund Hospital

Ålesund, Norway

RECRUITING

St Olavs University Hospital

Trondheim, Norway

RECRUITING

Related Publications (1)

  • Reidunsdatter RJ, Rannestad T, Frengen J, Frykholm G, Lundgren S. Early effects of contemporary breast radiation on health-related quality of life - predictors of radiotherapy-related fatigue. Acta Oncol. 2011 Nov;50(8):1175-82. doi: 10.3109/0284186X.2011.604345. Epub 2011 Aug 28.

    PMID: 21871005BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Breast NeoplasmsCardiovascular Diseases

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jo-Åsmund Lund, md phd

    St. Olavs Hospital

    STUDY CHAIR

Central Study Contacts

torgeir wethal, md phd

CONTACT

torgeir.wethal@stolav.no

Jo-Åsmund Lund, md phd

CONTACT

jo-asmund.lund@stolav.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 4, 2015

Study Start

November 1, 2016

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2036

Last Updated

June 4, 2026

Record last verified: 2026-06

Locations

NO(2)