Back to results

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

Primary Purpose

Breast Cancer, Cardiac Toxicity

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Subclinical cardiac lesions and biomarkers

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Radiotherapy, Echocardiography, Strain strain rate, Coronary computed tomography angiography, Segments of coronary arteries, Subclinical functional and anatomical cardiac lesions, Biomarkers, Heart dosimetry

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Clinique PasteurRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Breast cancer patients with 3DCRT

Arm Description

Measures of subclinical functional and anatomical cardiac lesions and circulating biomarkers 'Subclinical cardiac lesions and biomarkers'

Outcomes

Primary Outcome Measures

Number of patients with decreased myocardial function assessed by echocardiography

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

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 Outcome Measures

Decrease in the strain or strain rate

Modification in series of circulating biomarkers of cardiac lesions

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

Full Information

NCT ID

NCT02605512

First Posted

November 6, 2015

Last Updated

June 18, 2018

Sponsor

Sophie JACOB

Collaborators

Institut de Radioprotection et de Surete Nucleaire, Clinique Pasteur, Institut National de la Santé Et de la Recherche Médicale, France

1. Study Identification

Unique Protocol Identification Number

NCT02605512

Brief Title

BreAst Cancer and Cardiotoxicity Induced by RAdioTherapy: the BACCARAT Study

Acronym

BACCARAT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

September 2019 (Anticipated)

Study Completion Date

September 2020 (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, Clinique Pasteur, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

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

Breast Cancer, Cardiac Toxicity

Keywords

Radiotherapy, Echocardiography, Strain strain rate, Coronary computed tomography angiography, Segments of coronary arteries, Subclinical functional and anatomical cardiac lesions, Biomarkers, Heart dosimetry

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Breast cancer patients with 3DCRT

Arm Type

Other

Arm Description

Measures of subclinical functional and anatomical cardiac lesions and circulating biomarkers 'Subclinical cardiac lesions and biomarkers'

Intervention Type

Other

Intervention Name(s)

Subclinical cardiac lesions and biomarkers

Intervention Description

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 Outcome Measure Information:

Title

Number of patients with decreased myocardial function assessed by echocardiography

Description

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

Time Frame

2 years after 3DCRT (baseline measures performed before radiotherapy)

Title

Number of patients with increased coronary plaques assessed by CT coronary angiography

Description

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

Time Frame

2 years after 3DCRT (baseline measures performed before radiotherapy)

Secondary Outcome Measure Information:

Title

Decrease in the strain or strain rate

Time Frame

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

Title

Modification in series of circulating biomarkers of cardiac lesions

Description

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)

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sophie Jacob, PhD

Phone

+33630704719

sophie.jacob@irsn.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Atul Pathak, MD PhD

Organizational Affiliation

Clinique Pasteur Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique Pasteur

City

Toulouse

ZIP/Postal Code

31300

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Atul Pathak, MD PhD

apathak@clinique-pasteur.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

32819449

Citation

Walker V, Lairez O, Fondard O, Jimenez G, Camilleri J, Panh L, Broggio D, Bernier MO, Laurier D, Ferrieres J, Jacob S. Myocardial deformation after radiotherapy: a layer-specific and territorial longitudinal strain analysis in a cohort of left-sided breast cancer patients (BACCARAT study). Radiat Oncol. 2020 Aug 20;15(1):201. doi: 10.1186/s13014-020-01635-y.

Results Reference

derived

PubMed Identifier

31727075

Citation

Walker V, Lairez O, Fondard O, Pathak A, Pinel B, Chevelle C, Franck D, Jimenez G, Camilleri J, Panh L, Broggio D, Derreumaux S, Bernier MO, Laurier D, Ferrieres J, Jacob S. Early detection of subclinical left ventricular dysfunction after breast cancer radiation therapy using speckle-tracking echocardiography: association between cardiac exposure and longitudinal strain reduction (BACCARAT study). Radiat Oncol. 2019 Nov 14;14(1):204. doi: 10.1186/s13014-019-1408-8.

Results Reference

derived

PubMed Identifier

30732640

Citation

Jacob S, Camilleri J, Derreumaux S, Walker V, Lairez O, Lapeyre M, Bruguiere E, Pathak A, Bernier MO, Laurier D, Ferrieres J, Gallocher O, Latorzeff I, Pinel B, Franck D, Chevelle C, Jimenez G, Broggio D. Is mean heart dose a relevant surrogate parameter of left ventricle and coronary arteries exposure during breast cancer radiotherapy: a dosimetric evaluation based on individually-determined radiation dose (BACCARAT study). Radiat Oncol. 2019 Feb 7;14(1):29. doi: 10.1186/s13014-019-1234-z.

Results Reference

derived

PubMed Identifier

27056179

Citation

Jacob S, Pathak A, Franck D, Latorzeff I, Jimenez G, Fondard O, Lapeyre M, Colombier D, Bruguiere E, Lairez O, Fontenel B, Milliat F, Tamarat R, Broggio D, Derreumaux S, Ducassou M, Ferrieres J, Laurier D, Benderitter M, Bernier MO. Early detection and prediction of cardiotoxicity after radiation therapy for breast cancer: the BACCARAT prospective cohort study. Radiat Oncol. 2016 Apr 7;11:54. doi: 10.1186/s13014-016-0627-5.

Results Reference

derived

Learn more about this trial

BreAst Cancer and Cardiotoxicity Induced by RAdioTherapy: the BACCARAT Study

We'll reach out to this number within 24 hrs