REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• Institut de Radioprotection et de Surete Nucleaire

  collaborator OTHER_GOV

• Institut Claudius Regaud

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Sophie JACOB

  lead OTHER_GOV

Principal Investigators

• Carole Massabeau, MD · Institut Claudius Regaud, Toulouse (France)

• Marie-Odile Bernier, MD · Institut de Radioprotection et de Sureté Nucléaire, Fontenay-aux-Roses (France)

• Jean Ferrières, MD, PhD · University Hospital Rangueil, Toulouse (France)

• Hervé Rousseau, MD, PhD · University Hospital Rangueil, Toulouse (France)

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2018-11-30

Completion

2019-11-30

Countries

• France

Study Locations