Clinical trial · Interventional
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT for Breast Cancer. A Gender-based Preventive Medicine Approach
- 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)
This is a no-profit, national, monocenter, retrospective, and prospective low-intervention study. It is a low-intervention study in terms of diagnostic additional procedure (CT scan). It is planned to recruit a maximum of 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy from 2010 to 2017 at the European Institute of Oncology who meet all the inclusion and exclusion criteria. The aim of the Study is to analyze a population of breast cancer patients treated by adjuvant whole breast radiotherapy to identify the most important cardiovascular (CV) risk factors linked to coronary artery disease (CAD) development, in a cure-without-complications oncology strategy.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT scan and blood sample collection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm study
- description
- After signing the informed consent form, patients who meet all eligibility criteria will be enrolled in the Study. After execution of the CT scan the patient will be contacted to discuss the CT scan result. In case of high calcium score values, patients will be performing a cardiological medical examination, ECG, and further diagnostic investigations, as clinically indicated
- interventionNames
- Diagnostic Test: CT scan and blood sample collection
Primary outcomes (1)
- measure
- Primary Outcome Coronary calcium (CAC)
- timeFrame
- 2 years
- description
- Coronary calcium (CAC) assessment and its relationship with left-side or right-side breast radiation therapy and previously known cardiovascular risk factors. The quantification of CAC will be performed according to the Agatston score by multiplying the total CAC area in mm2 by a density factor ranging from 1 to 4 (1 for lesions with a density of 130-199 HU; 2 if the lesion has a density of 200-299 HU; 3 for lesions with a density of 300-399 HU; 4 for densities ≥400 HU)
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with early-stage breast cancer treated with adjuvant whole breast external beam radiotherapy from 2010 to 2017; * Patients with a \> 5 years clinical follow-up (FU) from diagnosis of breast cancer * Adult women/patients ≥18 years old and ≤ 60 years at time of radiation therapy; * Patients with homogeneous and standardized radiation exposure protocol (external beam radiotherapy 40 Gy in 15 fractions) * Patients who have signed the written informed consent Exclusion Criteria: * Patients aged \< 18 or \> 60 years at time of radiation therapy; * Patients with bilateral breast cancer or breast cancer of unknown laterality; * Patients with a prior diagnosis of invasive cancer (apart from non-melanoma skin cancer); * Patients with known active ischemic heart disease during or before the RT period; * Patients with no definitive surgery (e.g. a biopsy only); * Patients who did not receive radiotherapy were excluded from the Study. * Patients who are currently participating in an investigational interventional study. * IORT (Intraoperative radiotherapy) and PBI (partial breast radiotherapy) excluded * Participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to Study procedures
References
Publications (1)
- DERIVEDTrabattoni D, Leonardi MC, Mancini ME, Jereczek-Fossa BA, Cattani F, Santagostino Baldi G, Bonomi A, Galotta A, Mushtaq S, Annoni A, Alio D, Vincini MG, Fodor CI, La Grutta L, Montorsi P, Pontone G. Coronary artery calcium and cardiovascular risk factors analysis after radiotherapy for breast cancer (the CLARIFIER: a gender-based preventive medicine study). Front Cardiovasc Med. 2025 Aug 4;12:1615793. doi: 10.3389/fcvm.2025.1615793. eCollection 2025. PMID 40832141