BreAst Cancer and Cardiotoxicity Induced by RAdioTherapy: the BACCARAT Study (BACCARAT)

November 6, 2023 updated by: Sophie JACOB

Early Detection and Prediction of Cardiotoxicity in Radiotherapy-treated Breast Cancer Patients

Breast radiotherapy RT used until the 1990s was clearly responsible for increased mortality due to long term cardiac complications. Since the 2000s, improvements have appeared in dose distributions to organ at risks such as heart, but now, little is known on the risk of potential cardiac impairment in this population, in particular for chemotherapy naive patients. Based on the state that clinically detectable cardiotoxicity is generally preceded by subclinical cardiac dysfunctions, the aim of the BACCARAT study (BreAst Cancer and Cardiotoxicity induced by RAdioTherapy) is to evaluate whether adjuvant 3DCRT induces cardiac toxicity that could be detected in the first two years after treatment based on a global approach with repeated analysis of subclinical functional and anatomical cardiac lesions in myocardial and coronary levels and circulating biomarkers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACCARAT study consists in a monocentric prospective cohort study that will finally include 120 women treated with adjuvant RT for breast cancer in the Clinique Pasteur in Toulouse, and followed for 2 years after RT.

Women aged 50 to 70 years, treated for breast cancer and for whom adjuvant 3DCRT is indicated, without chemotherapy are eligible for the study.

Baseline and follow-up include measures of functional myocardial dysfunction based on 2D-speckle tracking echocardiography, anatomical coronary lesions based on Coronary computed tomography angiography, and a wide panel of circulating biomarkers. Absorbed doses is evaluated for whole heart and for each different parts of heart, in particular coronary arteries.

Analysis on occurrence and evolutions of subclinical cardiac lesions and biomarkers will be performed and completed with dose-response relations with absorbed doses of different heart segments.

Study Type

Interventional

Enrollment (Actual)

118

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, 31300
        • Clinique Pasteur

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

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 50 and 70 years
  • Women surgically treated for left or right breast cancer and for whom adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly ganglion chains,
  • Adjuvant radiotherapy with 3DCRT performed in Clinique Pasteur Toulouse
  • WHO performance status ECOG - Eastern Cooperative Oncology Group (index normally used to describe the patient's condition) = 0 or 1
  • Being volunteer to participate in the study and have signed the consent form

Exclusion Criteria:

  • Indication of adjuvant chemotherapy
  • Clinically or radiologically detectable metastasis
  • Personal history of coronary artery disease or myocardial disease
  • Personal history of breast cancer or other cancer requiring radiotherapy to the thorax
  • Patient with controlled infection or severe disease and / or non-hazardous to their participation in the study
  • Contraindications to injection of iodinated contrast (for CCTA): pregnancy, renal failure, allergy.
  • Pregnancy, lactation
  • Abnormal echocardiography before radiotherapy:
  • LVEF <50%
  • Longitudinal strain> - 16%
  • Longitudinal strain rate <1% / s
  • Abnormal wall motion
  • CCTA before radiotherapy showing that therapeutic management is required (coronary-artery calcium (CAC) score>600)

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: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Breast cancer patients with 3DCRT
Measures of subclinical functional and anatomical cardiac lesions and circulating biomarkers 'Subclinical cardiac lesions and biomarkers'
Other: Subclinical cardiac lesions and biomarkers
Functional myocardial dysfunction based on 2D-speckle tracking echocardiography, Anatomical coronary lesions based on Coronary computed tomography angiography, a panel of circulating biomarkers based on blood samples and plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with decreased myocardial function assessed by echocardiography
Time Frame: 2 years after 3DCRT (baseline measures performed before radiotherapy)
Number of patients with a decrease in the mean strain or strain rate measured from the echocardiography of the order of 5% between the measurement before RT and 24 months after RT
2 years after 3DCRT (baseline measures performed before radiotherapy)
Number of patients with increased coronary plaques assessed by CT coronary angiography
Time Frame: 2 years after 3DCRT (baseline measures performed before radiotherapy)
Number of patients with an increase of the average index of coronary plaques measured from the CT coronary angiography in the order of 15% between the measurements before RT and 24 months after RT
2 years after 3DCRT (baseline measures performed before radiotherapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in the strain or strain rate
Time Frame: 6 months after 3DCRTand 2 years after 3DCRT (baseline measures performed before radiotherapy)
6 months after 3DCRTand 2 years after 3DCRT (baseline measures performed before radiotherapy)
Modification in series of circulating biomarkers of cardiac lesions
Time Frame: 5 weeks after initiation of 3DCRT (corresponding to the end of 3DCRT sessions), 6 months after 3DCRTand 2 years after 3DCRT (baseline measures performed before radiotherapy)
Classical biomarkers of cardiac injury: C-reactive protein, Troponin I, B-type natriuretic peptide (NT-Pro BNP), beta2-Microglobulin, Galectin 3 / Inflammatory cytokines: Interleukin 6, Interleukin 8, Interleukin 18, TNF-α / Endothelial activation and dysfunction: sVCAM,-1 , s-ICAM-1, E-selectin, P-selectin , vWF, PAI-1, Fibrinogen , Thrombomodulin, TGF-β1 / Microparticles: CD14, CD31, CD41, CD3, CD235a / microRNAs : miR-1, miR-133, miR-208, miR-499, miR-126, miR-130, miR-145, miR-181, miR-150, miR-155, miR-223, miR-17, miR-18, miR-22, miR-34, miR-92, miR-140, miR-182, miR-199, miR-423, miR-590
5 weeks after initiation of 3DCRT (corresponding to the end of 3DCRT sessions), 6 months after 3DCRTand 2 years after 3DCRT (baseline measures performed before radiotherapy)
Correlation between the absorbed radiation dose by the whole heart and different structures of the heart and measurements of strain and strain rate and indices of coronary plaques
Time Frame: 2 years
2 years

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
Clinique Pasteur
Institut de Radioprotection et de Surete Nucleaire

Investigators

  • Principal Investigator: Atul Pathak, MD PhD, Clinique Pasteur Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 1, 2015

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimated)

November 16, 2015

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRSN_2015-A00990-49

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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