Status:
COMPLETED
Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer
Lead Sponsor:
Institut de Radioprotection et de Surete Nucleaire
Collaborating Sponsors:
Academisch Ziekenhuis Groningen
Technical University of Munich
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
40-75 years
Phase:
NA
Brief Summary
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-ind...
Detailed Description
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-conservi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03297346
Start Date
September 1 2017
End Date
May 31 2021
Last Update
November 7 2023
Active Locations (5)
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1
IRSN - Clinique Pasteur
Toulouse, France
2
Klinikum rechts der Isar der Technischen Universität München
Munich, Germany
3
Academisch Ziekenhuis Groningen
Groningen, Netherlands
4
Associação para Investigação e Desenvolvimento da Faculdade de Medicina
Lisbon, Portugal