NCT02605512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

4.3 years

First QC Date

November 6, 2015

Last Update Submit

November 6, 2023

Conditions

Breast CancerCardiac Toxicity

Keywords

RadiotherapyEchocardiographyStrain strain rateCoronary computed tomography angiographySegments of coronary arteriesSubclinical functional and anatomical cardiac lesionsBiomarkersHeart dosimetry

Outcome Measures

Primary Outcomes (2)

  • 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

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

  • 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

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

Secondary Outcomes (3)

  • Decrease in the strain or strain rate

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

  • Modification in series of circulating biomarkers of cardiac lesions

    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

    2 years

Study Arms (1)

Breast cancer patients with 3DCRT

OTHER

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

Other: Subclinical cardiac lesions and biomarkers

Interventions

Subclinical cardiac lesions and biomarkersOTHER

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

Breast cancer patients with 3DCRT

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Pasteur

Toulouse, 31300, France

Location

Related Publications (6)

  • Honaryar MK, Locquet M, Allodji R, Jimenez G, Pinel B, Lairez O, Panh L, Camilleri J, Broggio D, Ferrieres J, De Vathaire F, Jacob S. Cancer therapy-related cardiac dysfunction after radiation therapy for breast cancer: results from the BACCARAT cohort study. Cardiooncology. 2024 Aug 26;10(1):54. doi: 10.1186/s40959-024-00255-9.

    PMID: 39187877DERIVED

  • Honaryar MK, Allodji R, Jimenez G, Lapeyre M, Panh L, Camilleri J, Broggio D, Ferrieres J, De Vathaire F, Jacob S. Early Development of Atherosclerotic Plaques in the Coronary Arteries after Radiotherapy for Breast Cancer (BACCARAT Study). J Cardiovasc Dev Dis. 2023 Jul 12;10(7):299. doi: 10.3390/jcdd10070299.

    PMID: 37504555DERIVED

  • 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.

    PMID: 32819449DERIVED

  • 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.

    PMID: 31727075DERIVED

  • 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.

    PMID: 30732640DERIVED

  • 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.

    PMID: 27056179DERIVED

MeSH Terms

Conditions

Breast NeoplasmsCardiotoxicity

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

  • Atul Pathak, MD PhD

    Clinique Pasteur Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 16, 2015

Study Start

October 1, 2015

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations

FR(1)