REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)
- Conditions
- Toxicity Due to RadiotherapyBreast CancerLesion; Cardiac
- Interventions
- Other: Helical tomotherapy for breast cancer
- Registration Number
- NCT02079272
- Lead Sponsor
- Sophie JACOB
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Helical tomotherapy for breast cancer Helical tomotherapy for breast cancer 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
- Primary Outcome Measures
Name Time Method Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels within the first 2 years after tomotherapy 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 .
- Secondary Outcome Measures
Name Time Method Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam"2D 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)
Trial Locations
- Locations (1)
Institut Claudius Regaud
🇫🇷Toulouse, France