REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

Breast Cancer Clinical Trial

— REBECCA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02079272
• Other study ID #: 2013-A00929-36
• Status: Withdrawn
• Phase: N/A
• First received: February 26, 2014
• Last updated: April 3, 2015
• Start date: November 2014
• Est. completion date: November 2019

Study information

• Verified date: April 2015
• Source: Institut de Radioprotection et de Surete Nucleaire
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Institut Claudius Regaud	Toulouse

Sponsors (5)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels	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 .	within the first 2 years after tomotherapy	No
Secondary	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	No
Secondary	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)	No