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

Primary Purpose

Toxicity Due to Radiotherapy, Breast Cancer, Lesion; Cardiac

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Helical tomotherapy for breast cancer
Sponsored by
Sophie JACOB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Toxicity Due to Radiotherapy focused on measuring Tomotherapy, Breast Cancer, Heart, Subclinical cardiac lesions, Myocardial lesions, Coronary lesions, Circulating biomarkers, Ionizing radiation, Heart absorbed doses

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Institut Claudius Regaud

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Helical tomotherapy for breast cancer

Arm Description

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

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam"2D strain")
Number of participants with modified measures of circulating biomarkers

Full Information

First Posted
February 26, 2014
Last Updated
April 3, 2015
Sponsor
Sophie JACOB
Collaborators
Institut de Radioprotection et de Surete Nucleaire, Institut Claudius Regaud, University Hospital, Toulouse, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02079272
Brief Title
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)
Acronym
REBECCA
Official Title
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity): Evaluation of Radiation-induced Cardiotoxicity of Adjuvant Radiotherapy With Tomotherapy for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sophie JACOB
Collaborators
Institut de Radioprotection et de Surete Nucleaire, Institut Claudius Regaud, University Hospital, Toulouse, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Helical tomotherapy for breast cancer
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Helical tomotherapy for breast cancer
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels
Description
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 .
Time Frame
within the first 2 years after tomotherapy
Secondary Outcome Measure Information:
Title
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
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole Massabeau, MD
Organizational Affiliation
Institut Claudius Regaud, Toulouse (France)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie-Odile Bernier, MD
Organizational Affiliation
Institut de Radioprotection et de Sureté Nucléaire, Fontenay-aux-Roses (France)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Ferrières, MD, PhD
Organizational Affiliation
University Hospital Rangueil, Toulouse (France)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hervé Rousseau, MD, PhD
Organizational Affiliation
University Hospital Rangueil, Toulouse (France)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Learn more about this trial

REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

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