Clinical Trial: BreAst Cancer and Cardiotoxicity Induced by RAdioTherapy: the BACCARAT Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Sophie JACOB

Current Primary Outcome:

  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Decrease in the strain or strain rate [ Time Frame: 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
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Institut de Radioprotection et de Surete Nucleaire

Dates:
Date Received: November 6, 2015
Date Started: October 2015
Date Completion: September 2020
Last Updated: March 1, 2017
Last Verified: March 2017