REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity) (REBECCA)

April 3, 2015 updated by: Sophie JACOB

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • Institut Claudius Regaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels
Time Frame: 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 .
within the first 2 years after tomotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam"2D strain")
Time Frame: within the first 6 months after tomotherapy
within the first 6 months after tomotherapy
Number of participants with modified measures of circulating biomarkers
Time Frame: within the first 2 years after tomotherapy (at the end of radiotherapy, 6 months after radiotherapy and 24 months maximum after radiotherapy)
within the first 2 years after tomotherapy (at the end of radiotherapy, 6 months after radiotherapy and 24 months maximum after radiotherapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sophie JACOB

Collaborators

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

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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (ESTIMATE)

March 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 3, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00929-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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