Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

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

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

Helical tomotherapy for breast cancer

Carole Massabeau, MD

Marie-Odile Bernier, MD

Jean Ferrières, MD, PhD

Hervé Rousseau, MD, PhD

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.

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

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 .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)	NCT02079272	Toxicity Due to... Breast Cancer Lesion; Cardiac	Helical tomothe...	40 Years - 70 Years	Institut de Radioprotection et de Surete Nucleaire
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)	NCT02079272	Toxicity Due to... Breast Cancer Lesion; Cardiac	Helical tomothe...	40 Years - 70 Years	Institut de Radioprotection et de Surete Nucleaire
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)	NCT02079272	Toxicity Due to... Breast Cancer Lesion; Cardiac	Helical tomothe...	40 Years - 70 Years	Institut de Radioprotection et de Surete Nucleaire
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)	NCT02079272	Toxicity Due to... Breast Cancer Lesion; Cardiac	Helical tomothe...	40 Years - 70 Years	Institut de Radioprotection et de Surete Nucleaire

Spots Global Cancer Trial Database for helical tomotherapy for breast cancer