REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

N/AWithdrawnNCT02079272

Sophie JACOB

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Toxicity Due to Radiotherapy Breast Cancer Lesion; Cardiac

Interventions

Helical tomotherapy for breast cancerOTHER

1. 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 2. Helical tomotherapy will be performed for all women included in the cohort. 3. 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

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Claudius Regaud

Toulouse, France

Outcomes

Primary Outcomes

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 exam"2D 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 .

Time frame: within the first 2 years after tomotherapy

Secondary Outcomes

Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam"2D strain")

Time frame: within the first 6 months after tomotherapy

Number of participants with modified measures of circulating biomarkers

Time frame: within the first 2 years after tomotherapy (at the end of radiotherapy, 6 months after radiotherapy and 24 months maximum after radiotherapy)

Data from ClinicalTrials.gov

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