Prospective International Study Validating Sonographic Glandular Tissue Component to Predict Breast Cancer Risk in Women With Dense Breasts Aged 40 to 69

What this Trial Is About

This research aims to prospectively validate the association between the amount of glandular tissue seen on breast ultrasound, called sonographic glandular tissue component GTC, and the risk of developing breast cancer in women with dense breast tissue. Dense breasts can vary in cancer risk due to differences in tissue composition, and this study seeks to confirm if sonographic GTC adds important information beyond known risk factors. The study is international and multicenter, focusing on women aged 40 to 69 with dense breasts as seen on mammograms. Participants will undergo screening breast ultrasound using either automated or handheld devices, where the level of glandular tissue will be assessed and categorized as minimal, mild, moderate, or marked. These categories will be grouped into low versus high GTC levels. Women will be observed for breast cancer diagnosis, including invasive cancer and ductal carcinoma in situ, for up to 7 years following the ultrasound assessment. The study also collects detailed personal and medical information to analyze how sonographic GTC relates to breast cancer risk in combination with other factors. During the study, participants will provide information about age, race, menopausal status, family history, breast density, past biopsies, body mass index, reproductive history, and hormone therapy use. Researchers will track breast cancer occurrence starting 3 months after the ultrasound and will compare cancer risk based on GTC levels. They will also evaluate how well existing breast cancer risk models perform when sonographic GTC is included. Follow-up will continue for up to 7 years to monitor outcomes and breast ultrasound diagnostic performance.

Breast Cancer Risk From Sonographic Glandular Tissue Component (or International GTC Study)