REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.

Detailed Description
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REBECCA study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the Institut Regaud Claudius-Toulouse (ICR) and followed for 2 years after radiotherapy. In summary, women aged between 40 and 70 years, surgically treated at ICR for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.

Official Title
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REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity): Evaluation of Radiation-induced Cardiotoxicity of Adjuvant Radiotherapy With Tomotherapy for Breast Cancer

Conditions
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Lesion; Cardiac, Toxicity Due to Radiotherapy, Breast Cancer

Intervention / Treatment
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* Other: Helical tomotherapy for breast cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women treated surgically for left or right breast cancer and for who adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly lymph node chains, Age between 40 and 70 years Adjuvant Radiotherapy is helical tomotherapy performed at Institut Claudius Regaud(Toulouse, France) Exclusion Criteria: Indication of adjuvant chemotherapy Clinically or radiologically detectable metastasis Personal history of coronary artery or myocardial disease Personal history of breast cancer or other cancer requiring radiotherapy to the chest Contraindications to injection of iodinated contrast ( for CT ) : pregnancy , renal failure, allergy. Pregnancy, lactation Before radiotherapy, LVEF <50% Before radiotherapy, longitudinal strain > - 16 % Before radiotherapy,longitudinal strain rate <1% / s Before radiotherapy, segmental wall motion abnormality Coronary CT before radiotherapy showing that a therapeutic treatment is required

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Helical tomotherapy for breast cancer<br>All women included in REBECCA cohort will be treated with helical tomotherapy for theur breast cancer. Their cardiac follow-up will be based on echocardiography, CT coronary angiogram and blood samples | Other: Helical tomotherapy for breast cancer<br>* At baseline, before helical tomotherapy is performed, for each included woman will have: measures of biomarkers of cardiac injury based on blood samples (including CRP, NT-Pro BNP, …, microparticles and miRNA) cardiologic examination including echocardiography for measurement of strain and strain rate a CT coronary angiogram for measurement of coronary plaque indexes Helical tomotherapy will be performed for all women included in the cohort. At the end of tomotherapy, follow-up will include: measures of biomarkers: at the end of radiotherapy, 6 months and 24 months after radiotherapy cardiologic examinations including a echocardiography 6 and 24 months after radiotherapy A CT coronary angiogram 24 months after radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels | The primary outcome is defined as a decrease of at least 5% in strain or strain rate measures based on cardiac ultrasound exam2D strain between the measurement before radiotherapy and measures 24 months after radiotherapy and / or an increase of at least 15% in the average index of coronary plaques measured with CT coronary angiogram between the measurement before radiotherapy and measures 24 months after radiotherapy . | within the first 2 years after tomotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam2D strain) |  | within the first 6 months after tomotherapy | 
| Number of participants with modified measures of circulating biomarkers |  | within the first 2 years after tomotherapy (at the end of radiotherapy, 6 months after radiotherapy and 24 months maximum after radiotherapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tomotherapy, Breast Cancer, Heart, Subclinical cardiac lesions, Myocardial lesions, Coronary lesions, Circulating biomarkers, Ionizing radiation, Heart absorbed doses