Ongoing Clinical Trials for Breast Cancer in Situ
There are currently 2 ongoing clinical trials focused on breast cancer in situ. These studies are exploring advanced imaging techniques for better detection and classification of breast lesions, as well as prevention strategies for women at high risk of developing breast cancer. Both trials are being conducted in Italy.
Clinical trial locations
- Italy
Study on Detecting and Classifying Breast Disease Using Iodixanol in Digital Mammography and Tomosynthesis Compared to MRI in Patients with Breast Pathology
This trial focuses on comparing different imaging techniques to detect and classify breast lesions. The study evaluates whether Digital Mammography with Contrast Medium (CEDM), used alone or combined with Tomosynthesis (a type of 3D mammography), can provide results as accurate as Magnetic Resonance Imaging (MRI) with Gadolinium.
Inclusion criteria: Participants must be over 18 years old with a suspected or confirmed breast condition. They need to have recent kidney function test results showing an estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m², which indicates healthy kidney function. The condition should be suspected based on standard imaging tests like ultrasound or traditional 2D mammography, or confirmed through cytological or histopathological examination. Participants must provide informed consent and can have the required exams done at any point in their menstrual cycle.
Exclusion criteria: Males cannot participate in this study, and it is only open to females with breast pathology. Individuals outside specific age ranges or those considered part of vulnerable populations are excluded. Vulnerable populations include people who may have limited ability to provide informed consent or are at higher risk of harm.
Main focus: The trial aims to determine if CEDM, with or without tomosynthesis, is as effective as MRI in detecting breast lesions and identifying whether they are present in multiple areas of one or both breasts. The study also evaluates the ability of these imaging techniques to classify lesions as benign or malignant and to identify specific tumor types, such as luminal A, luminal B, HER2-positive, and triple-negative.
Investigational approach: The study uses a special contrast agent called Visipaque (containing iodixanol), which is injected into the body to enhance visibility during digital mammography and tomosynthesis. This is compared to the standard approach of using Gadolinium as a contrast agent during MRI scans. The goal is to provide clearer, more detailed images that can improve diagnosis and treatment planning.
Study on Breast Cancer Prevention in High-Risk Women Using Low Dose Tamoxifen and Lifestyle Changes
This clinical trial focuses on preventing breast cancer in women who are at increased risk due to genetic factors or previous medical conditions. The study examines whether low dose Tamoxifen, alone or combined with lifestyle changes, can help reduce the risk of developing breast cancer.
Inclusion criteria: Participants must be women aged between 18 and 70 years old who are healthy but at higher risk. This includes women who carry genetic mutations in genes such as BRCA1, BRCA2, PALB2, ATM, CHEK2, CDH1, RAD51C, or RAD51D. It also includes women with a breast cancer risk greater than 5% over the next 10 years according to risk models, or those who have been previously diagnosed and surgically treated for intraepithelial neoplasia (such as ADH, LCIS, or ER positive DCIS) within the last 3 years. Participants must be able to carry out daily activities with an ECOG performance status of 0 or 1, or a Karnofsky score of 70% or higher. Recent negative mammogram and transvaginal ultrasound results are also required.
Exclusion criteria: Women outside the age range of 18 to 70 years are excluded. Men cannot participate in this study. Women who do not carry the specified genetic mutations, do not have a breast cancer risk greater than 5% over the next 10 years, or have not been previously treated for breast intraepithelial neoplasia are not eligible.
Main focus: The primary goal is to determine if Low Dose Tamoxifen can increase levels of Sex Hormone Binding Globulin (SHBG), a protein in the blood, more effectively than lifestyle changes alone. The study will monitor participants for six months with regular check-ups to assess SHBG levels, as well as other factors such as insulin, glucose levels, and body composition. Participants are randomly assigned to one of four groups, receiving either Low Dose Tamoxifen, lifestyle modifications, or a combination of both.
Investigational drugs and interventions: The medication being tested is Low Dose Tamoxifen (Nolvadex), taken as a 10 mg film-coated tablet orally each day. Tamoxifen works by blocking the effects of estrogen, a hormone that can promote breast cancer cell growth. The lifestyle intervention includes changes to diet, increased physical activity, and possibly intermittent caloric restriction to improve overall health and potentially lower breast cancer risk by affecting hormone levels.
Summary
Both clinical trials are being conducted in Italy and focus on different aspects of breast cancer management. The first trial explores advanced imaging techniques to improve the detection and classification of breast lesions, comparing contrast-enhanced digital mammography and tomosynthesis with the standard MRI approach. The second trial investigates prevention strategies for women at high genetic or clinical risk, testing whether Low Dose Tamoxifen combined with lifestyle modifications can effectively reduce the likelihood of developing breast cancer.
The imaging study uses iodixanol (Visipaque) as a contrast agent, while the prevention study focuses on Tamoxifen, a well-established medication in breast cancer treatment and prevention. Together, these trials represent important efforts to improve early detection and prevention strategies for those at risk of breast cancer.
