Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Breast cancer (BC) radiotherapy leads to coincidental radiation of the heart, resulting in increased risk of a variety of heart diseases. Identifying BC patients with the highest risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention. Little has been done on the relationship between dose distribution to different anatomical cardiac structures during radiotherapy and early cardiovascular changes that may lead to cardiac complications.

In the framework of the European project MEDIRAD, the EARLY-HEART multicenter prospective cohort was launched in August 2017, involving 5 investigating centers from France, Netherlands, Germany, Spain and Portugal. With 250 BC patients prospectively followed for 2 years, the main objective is to identify and validate the most important cardiac imaging (echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging) and circulating biomarkers of radiation-induced cardiovascular changes arising in the first 2 years after BC radiotherapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events

NCT03211442

Breast Cancer Female Acute Coronary Events Cardiac Complications

COMPLETED

Radiation-induced Toxicity of the Heart

NCT06986291

Non-small Cell Lung Cancer Esophageal Cancer Breast Cancer Female

NOT_YET_RECRUITING NA

Pilot Study of Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy

NCT02494453

Breast Cancer

COMPLETED

Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)

NCT03301389

Chemotherapy Induced Cardiotoxicity

UNKNOWN

Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy

NCT02496260

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

EARLY-HEART is a multicentre prospective cohort study that will include 250 female primary breast cancer cases aged 40-75 years treated with postoperative radiotherapy (RT) alone after breast-conserving surgery using modern planning-CT based RT technologies and followed for 2 years after RT in one of the 5 participating hospitals. In addition to the standard follow-up, patients will need to give repeated blood samples and will undergo repeated cardiac imaging:

* Functional and anatomical cardiac imaging biomarkers will be based on automated 2D-speckle-tracking echocardiography (ECHO-ST); Computed Tomography Coronary Angiography (CT) and cardiac magnetic resonance imaging (MRI).
* Circulating biomarkers (BLOOD) will be based on a panel of multiple classical or novel blood-based biomarkers.

Imaging and circulating biomarkers measurements will be assessed at baseline before RT (ECHO, CT, MRI, BLOOD); at the end of RT (BLOOD); 6 months after RT (ECHO, MRI, BLOOD) and 24 months after RT (ECHO, CT, MRI, BLOOD).

Changes in functional and anatomical cardiac imaging and circulating biomarkers between unexposed status before RT and exposed status after RT at different time points will be first analysed to evaluate the effects of RT on the heart.

All relevant DICOM-data (including planning-CT scans and the ECHO, MRI and CT) will be centralized to the MEDIRAD-ENACT database managed by University of Groningen for automated segmentation of all cardiac substructures (including coronary arteries) to ensure uniformity of the segmentation procedure between centres. The RT planning CTs will be used to generate dose volume histograms and 3D dose maps of the heart and cardiac substructures in order to correlate the localization of any cardiovascular change with the anatomical dose distribution.

In the presence of a cardiac outcome, a multimetric Normal Tissue Complication Probability (NTCP) individual risk model will be constructed and an integrative clinical-biologic risk score will be developed for individual risk prediction.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Female

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Breast cancer patients treated with RT

Cardiac imaging and circulating biomarkers measurements to evaluate:

* myocardial dysfunction and deformation (ECHO-ST)
* coronary artery lesions and coronary artery calcium score (CT)
* myocardium including tissue abnormalities, cardiac morphology and function (MRI)
* blood-based biomarkers of cardiovascular changes (BLOOD)

Group Type OTHER

Cardiac imaging and circulating biomarkers

Intervention Type OTHER

Automated 2D-speckle-tracking echocardiography (ECHO-ST); Computed tomography coronary angiography (CT); Cardiac magnetic resonance imaging (MRI); Blood samples for circulating biomarkers measurements (BLOOD)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cardiac imaging and circulating biomarkers

Automated 2D-speckle-tracking echocardiography (ECHO-ST); Computed tomography coronary angiography (CT); Cardiac magnetic resonance imaging (MRI); Blood samples for circulating biomarkers measurements (BLOOD)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female unilateral breast cancer patients
* Treated with primary breast conserving surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS)
* Age between 40-75 years at time of start radiotherapy
* World Health Organisation (WHO) performance status 0-1
* Planned for radiotherapy alone to the breast with or without the lymph node areas
* Radiotherapy based on planning-CT scan using either three dimensional conformal radiation therapy (3D-CRT), Intensity-modulated radiotherapy (IMRT), or Volumetric Arc Therapy (VMAT/RapidArc)
* Written Informed consent

Exclusion Criteria

* Male breast cancer patients
* Neoadjuvant or adjuvant chemotherapy
* M1 disease (metastatic breast cancer)
* Medical history of coronary artery disease and/or myocardial infarction and/or atrial fibrillation
* Previous thoracic or mediastinal radiation
* Contraindications to injection of iodinated contrast such as allergy or renal failure
* Pregnancy or lactation
* Atrial fibrillation detected during electrocardiogram before radiotherapy
* Abnormal echocardiography before radiotherapy defined as: Left Ventricular Ejection Fraction\<50%; longitudinal strain ≤ -16%; longitudinal strain rate \<-1%, and/or abnormal wall motion
* Presence of myocardial infarction detected during MRI before radiotherapy
* CT or MRI results before radiotherapy requiring revascularisation

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes