Clinical trial · Interventional
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity): Evaluation of Radiation-induced Cardiotoxicity of Adjuvant Radiotherapy With Tomotherapy for Breast Cancer
- 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)
The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.
Conditions
Conditions (3)
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 |
| Lesion; Cardiac | — | UNRESOLVED | — |
| Toxicity Due to Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Helical tomotherapy for breast cancer | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Helical tomotherapy for breast cancer
- description
- All women included in REBECCA cohort will be treated with helical tomotherapy for theur breast cancer. Their cardiac follow-up will be based on echocardiography, CT coronary angiogram and blood samples
- interventionNames
- Other: Helical tomotherapy for breast cancer
Primary outcomes (1)
- measure
- Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels
- timeFrame
- within the first 2 years after tomotherapy
- description
- The primary outcome is defined as a decrease of at least 5% in strain or strain rate measures based on cardiac ultrasound exam"2D strain" between the measurement before radiotherapy and measures 24 months after radiotherapy and / or an increase of at least 15% in the average index of coronary plaques measured with CT coronary angiogram between the measurement before radiotherapy and measures 24 months after radiotherapy .
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women treated surgically for left or right breast cancer and for who adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly lymph node chains, * Age between 40 and 70 years * Adjuvant Radiotherapy is helical tomotherapy performed at Institut Claudius Regaud(Toulouse, France) Exclusion Criteria: * Indication of adjuvant chemotherapy * Clinically or radiologically detectable metastasis * Personal history of coronary artery or myocardial disease * Personal history of breast cancer or other cancer requiring radiotherapy to the chest * Contraindications to injection of iodinated contrast ( for CT ) : pregnancy , renal failure, allergy. * Pregnancy, lactation * Before radiotherapy, LVEF \<50% * Before radiotherapy, longitudinal strain \> - 16 % * Before radiotherapy,longitudinal strain rate \<1% / s * Before radiotherapy, segmental wall motion abnormality * Coronary CT before radiotherapy showing that a therapeutic treatment is required
References
Publications (0)
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