REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

NCT02079272 | Withdrawn

• 1 other identifier: 2013-A00929-36
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxicity Due to Radiotherapy; Breast Cancer; Lesion; Cardiac

Keywords

Tomotherapy; Breast Cancer; Heart; Subclinical cardiac lesions; Myocardial lesions; Coronary lesions; Circulating biomarkers; Ionizing radiation; Heart absorbed doses

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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)

Study Arms (1)

Helical tomotherapy for breast cancer

OTHER

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

Interventions

Helical tomotherapy for breast cancer 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

Helical tomotherapy for breast cancer

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Institut Claudius Regaud

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 5, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: April 6, 2015

Record last verified: 2015-04

Locations

FR (1)