REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

Sponsor

Sophie JACOB (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02079272

Collaborator

Institut de Radioprotection et de Surete Nucleaire (Other), Institut Claudius Regaud (Other), University Hospital, Toulouse (Other), Institut National de la Santé Et de la Recherche Médicale, France (Other)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Toxicity Due to Radiotherapy Breast Cancer Lesion; Cardiac	Other: Helical tomotherapy for breast cancer	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Other: Helical tomotherapy for breast cancer 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 Helical tomotherapy will be performed for all women included in the cohort. 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

Arm

Intervention/Treatment

Other: 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

Other: Helical tomotherapy for breast cancer

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 Helical tomotherapy will be performed for all women included in the cohort. 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

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Claudius Regaud	Toulouse		France	31000

Sponsors and Collaborators

Sophie JACOB
Institut de Radioprotection et de Surete Nucleaire
Institut Claudius Regaud
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator: Carole Massabeau, MD, Institut Claudius Regaud, Toulouse (France)
Principal Investigator: Marie-Odile Bernier, MD, Institut de Radioprotection et de Sureté Nucléaire, Fontenay-aux-Roses (France)
Principal Investigator: Jean Ferrières, MD, PhD, University Hospital Rangueil, Toulouse (France)
Principal Investigator: Hervé Rousseau, MD, PhD, University Hospital Rangueil, Toulouse (France)