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NCT Number: NCT02605512

BreAst Cancer and Cardiotoxicity Induced by RAdioTherapy: the BACCARAT Study

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cardiac Toxicity Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Pasteur

Toulouse, 31300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Subclinical cardiac lesions and biomarkers

Other

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

Primary outcomes

  1. 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. 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

Secondary outcomes

  1. Decrease in the strain or strain rate

    Time frame: 6 months after 3DCRTand 2 years after 3DCRT (baseline measures performed before radiotherapy)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Sophie JACOB

Other Gov

Collaborators

  • Clinique Pasteur
  • French Nuclear Safety and Radiation Protection Authority (ASNR)
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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

Acronym: BACCARAT

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 16, 2015
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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