REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

NCT ID: NCT02079272

Last Updated: 2015-04-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2019-11-30

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.

Conditions

Toxicity Due to Radiotherapy; Breast Cancer; Lesion; Cardiac

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Helical tomotherapy for breast cancer

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut de Radioprotection et de Surete Nucleaire

OTHER_GOV

Sponsor Role: collaborator

Institut Claudius Regaud

OTHER

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: collaborator

Sophie JACOB

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sophie JACOB

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carole Massabeau, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud, Toulouse (France)

Marie-Odile Bernier, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Radioprotection et de Sureté Nucléaire, Fontenay-aux-Roses (France)

Jean Ferrières, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Rangueil, Toulouse (France)

Hervé Rousseau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Rangueil, Toulouse (France)

Locations

Institut Claudius Regaud

Toulouse, , France

Countries

France

Other Identifiers

2013-A00929-36

Identifier Type: -

Identifier Source: org_study_id