NCT02079272

REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sophie JACOB · Other Government
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Toxicity Due to Radiotherapy
• Breast Cancer
• Lesion; Cardiac

Interventions

Type	Name	Description
OTHER	Helical tomotherapy for breast cancer	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

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-11-01
• Completion: 2019-11-01
• First posted: 2014-03-05
• Last updated: 2015-04-06

Locations

1 site across 1 country: France