Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer

NCT05775822 | Completed

• 1 other identifier: CCM 1505
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Breast cancer; Coronary Artery Disease; Calcium Score; Radiotherapy; Cardiovascular events; CV risk factors; Cardio-oncology

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Coronary calcium (CAC)

  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)

  2 years

Secondary Outcomes (2)

• Outcome 2 circulating markers

  2 years

• Outcome 3 Incidence of CV events

  2 years

Study Arms (1)

Single arm study

OTHER

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

Diagnostic Test: CT scan and blood sample collection

Interventions

CT scan and blood sample collection DIAGNOSTIC_TEST

Each enrolled patient performs: * preventive clinical cardiology assessment visit, addressed to individualized risk profile assessment and addressed to chest CT scan. * a blood sampling (1 citrate tube of 5 ml) will be done the same day just the chest CT scan and analyzed locally also for future research of biomarker discovery (single sample, for those patients who agree in ICF) * CT scan

Single arm study

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy from 2010 to 2017 at European Institute of Oncology
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Istituto Europeo di Oncologia: collaborator

Study Sites (1)

IRCCS Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Related Publications (1)

• Trabattoni 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Coronary Artery Disease

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Daniela Trabattoni, MD

  IRCCS Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 20, 2023
• Study Start: March 24, 2022
• Primary Completion: December 20, 2023
• Study Completion: January 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2023-03

Locations

IT (1)