Clinical trial · Interventional
BreAst Cancer and Cardiotoxicity Induced by RAdioTherapy: the BACCARAT Study
Early Detection and Prediction of Cardiotoxicity in Radiotherapy-treated Breast Cancer Patients
NCT02605512CI-TRIAL-00071165BACCARATcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiac Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Subclinical cardiac lesions and biomarkers | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Breast cancer patients with 3DCRT
- description
- Measures of subclinical functional and anatomical cardiac lesions and circulating biomarkers 'Subclinical cardiac lesions and biomarkers'
- interventionNames
- Other: Subclinical cardiac lesions and biomarkers
Primary outcomes (2)
- measure
- Number of patients with decreased myocardial function assessed by echocardiography
- timeFrame
- 2 years after 3DCRT (baseline measures performed before radiotherapy)
- 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
- measure
- Number of patients with increased coronary plaques assessed by CT coronary angiography
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (6)
- DERIVEDHonaryar 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 39187877
- DERIVEDHonaryar 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 37504555
- DERIVEDWalker 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 32819449
- DERIVEDWalker 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 31727075
- DERIVEDJacob 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 30732640