Early Detection of Cardiovascular Risk in Breast Cancer Using Planning CT Before Radiation Therapy

Breast cancer develops when cells in the glandular tissue of the breast multiply uncontrollably. In most cases, the changes originate in the transitional zone between the milk ducts and the lobules. In ductal carcinoma in situ (DCIS), the abnormal cells are still confined to the milk ducts and have not invaded the surrounding tissue; this is therefore referred to as a non-invasive early-stage form or precursor (Stage 0). Today, breast cancer is usually detected early and can be effectively treated in many cases, allowing many patients to live long lives both during and after the disease. However, longer survival is associated in the long term with a higher burden of chronic diseases, particularly cardiovascular diseases, which occur more frequently in former breast cancer patients than in the general population. This increased risk is attributable, among other things, to treatment-related effects, such as those caused by chemotherapy and radiation therapy. Cardiovascular diseases affect the heart and blood vessels. The most common conditions include high blood pressure, coronary heart disease (CHD), and heart attack. Calcifications in the coronary arteries (coronary calcium) are considered a sign of atherosclerosis and indicate an increased risk of cardiovascular disease. They can be visualized using computed tomography (CT) and described using the so-called Agatston score, which is calculated based on the number, area, and density of the calcified lesions. A higher score indicates more severe calcification. A planning CT scan of the chest is performed prior to radiation therapy anyway, and such calcium deposits are visible on this scan. This planning CT scan is used for the study.

The goal of the ARTILLERY-CarDI study is to determine the Agatston score based on the planning CT scan and to derive the estimated cardiovascular risk from it. The result is then communicated to patients and their treating physicians along with a recommendation. The recommendation may, for example, be that no further action is necessary, or patients may receive lifestyle recommendations or a referral to a cardiologist or their primary care physician for further cardiovascular care. The main goal is to examine how this information affects cancer treatment and ongoing cardiovascular care, and how satisfied patients are with their decision to learn about their personal risk in the first place. Disclosing individual cardiovascular risk and providing tailored care are intended to help patients take an active role in managing their health and to raise awareness of cardiovascular diseases in breast cancer patients, including from a medical perspective. At the same time, the study aims to determine whether patients develop increased anxiety as a result, leading to dissatisfaction or regret regarding their decision. The study is open-label (not blinded), which means that both the patients and the study physicians know which test is being performed. Over a period of about one and a half years, a total of 1,000 breast cancer patients in four countries (the Netherlands, Germany, Portugal, and Denmark) will be enrolled in the study. Each patient will be followed for six months.

Patients aged 35 and older who have been diagnosed with breast cancer or a non-invasive precancerous condition (ductal carcinoma in situ, DCIS) and who are scheduled to undergo radiation therapy are eligible to participate. Patients who are pregnant or breastfeeding are excluded from participation.