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Breast CancerBACCARATNCT02605512

BreAst Cancer and Cardiotoxicity Induced by RAdioTherapy: the BACCARAT Study

A study testing Subclinical cardiac lesions and biomarkers in people with Breast Cancer and Cardiac Toxicity, run by Sophie JACOB at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 70 years, women only
Conditions the study is for
Breast Cancer, Cardiac Toxicity
What is being tested?
Subclinical cardiac lesions and biomarkers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteFrance
Study dates
Oct 2015to Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Clinique Pasteur

    Toulouse, 31300

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Subclinical cardiac lesions and biomarkers
Keywords
Radiotherapy, Echocardiography, Strain strain rate, Coronary computed tomography angiography, Segments of coronary arteries, Subclinical functional and anatomical cardiac lesions, Biomarkers, Heart dosimetry
Medical subject headings
Breast Neoplasms, Cardiotoxicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT02605512
Study groupRoleWhat they receive
Breast cancer patients with 3DCRTOtherMeasures of subclinical functional and anatomical cardiac lesions and circulating biomarkers 'Subclinical cardiac lesions and biomarkers'
Receives: Other: Subclinical cardiac lesions and biomarkers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

Secondary outcomes (3)

  1. Decrease in the strain or strain rate

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

  2. 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

    Measured: 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)

  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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionFeb 2020
  4. Study completionFeb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02605512
Sponsor's protocol ID
IRSN_2015-A00990-49
Acronym
BACCARAT
Status last verified
Nov 2023
First submitted
6 Nov 2015
Last updated
8 Nov 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39187877

  • 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.

    PubMed 37504555

  • 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.

    PubMed 32819449

  • 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.

    PubMed 31727075

  • 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.

    PubMed 30732640

  • 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.

    PubMed 27056179

Questions about this trial

What is this clinical trial studying?

A study testing Subclinical cardiac lesions and biomarkers in people with Breast Cancer and Cardiac Toxicity, run by Sophie JACOB at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with decreased myocardial function assessed by echocardiography (time frame: 2 years after 3DCRT (baseline measures performed before radiotherapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02605512, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.

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