Clinical trial · Observational
Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events
Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events (MEDIRAD-BRACE): A Retrospective Cohort Study
- 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)
MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac structures and the risk of acute coronary events (ACE) and other cardiac complications in breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue Complication Probability (NTCP) models to assess the risk of ACE in individual patients based on cardiac dose metrics in the first 10 years after BC radiotherapy.
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 |
|---|---|---|---|
| Acute Coronary Events | — | UNRESOLVED | — |
| Breast Cancer Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Cardiac Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients with an Acute Coronary Event after completion of RT treatment
- timeFrame
- First 10 years after RT treatment
Secondary outcomes (2)
- measure
- Number of patients with other cardiac complications after completion of RT treatment
- timeFrame
- First 10 years after RT treatment
- measure
- Number of patients with radiotherapy-induced late non-cardiac toxicity (e.g. secondary tumors)
- timeFrame
- First 10 years after RT treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female breast cancer patients; * Treated with primary surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS); * Age between 40-75 years at time of start RT; * WHO performance status 0-1; * Planned for RT alone to the breast, the chest wall and/or the lymph node areas; * Start of RT is between 01-01-2015 and 31-12-2013; * Available planning CT scan and dose distribution; * Adjuvant systemic treatment, including hormonal therapy or chemotherapy is allowed; * Medical history of coronary artery disease and/or myocardial infarction is not an exclusion criterion; * Written informed consent. Exclusion Criteria: * Male breast cancer patients; * Women with metastatic breast cancer (M1 disease); * Any prior malignancy other than non-melanoma skin cancer; * Previous thoracic or mediastinal radiation; * Women treated with neoadjuvant chemotherapy.
References
Publications (1)
- DERIVEDErrahmani MY, Locquet M, Spoor D, Jimenez G, Camilleri J, Bernier MO, Broggio D, Monceau V, Ferrieres J, Thariat J, Boveda S, Kirova Y, Loap P, Langendijk JA, Crijns A, Jacob S. Association Between Cardiac Radiation Exposure and the Risk of Arrhythmia in Breast Cancer Patients Treated With Radiotherapy: A Case-Control Study. Front Oncol. 2022 Jul 4;12:892882. doi: 10.3389/fonc.2022.892882. eCollection 2022. PMID 35860581