Clinical trial NCT05775822: Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer
Official title: Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT for Breast Cancer. A Gender-based Preventive Medicine Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Coronary Artery Disease
Calcium Score
Radiotherapy
Cardiovascular events
CV risk factors
Cardio-oncology
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: Istituto Europeo di Oncologia
First posted: 2023-03-20
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Detailed description: In the present study a pre-screening activity is planned, that will be conducted by the European Institute of Oncology (IEO) at the Division of Radiotherapy. It will be done to identify and select from the IEO's database about 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy, from 2010 to 2017, and with a \> 5 years clinical Follow up (FU). All patients, who present pre-specified RT treatment, in terms of radiation exposure, and radiation protocol (IORT excluded as well as previous RT treatments), will be proposed to participate in the Study. The researcher of the IEO will contact by phone each identified patient (eligible patients) to request her interest in participating in the present study and to obtain her availability to be contacted by the Investigator of Centro Cardiologico Monzino (CCM) to define all aspects and activities planned in the protocol.

Patients who meet all eligibility criteria, after signing the informed consent form, at Centro Cardioogico Monzino, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome Coronary calcium (CAC)
timeFrame: 2 years
Secondary outcomes:
measure: Outcome 2 circulating markers
timeFrame: 2 years
measure: Outcome 3 Incidence of CV events
timeFrame: 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Centro Cardiologico Monzino
Study officials:
affiliation: IRCCS Centro Cardiologico Monzino
name: Daniela Trabattoni, MD
role: PRINCIPAL_INVESTIGATOR
References: