The Clinical Problem

In 2011, an estimated 230,480 new cases of invasive breast cancer will be diagnosed in women in the United States, as well as an estimated 57,650 additional cases of in situ breast cancer. In 2011 about 39,520 will die from this devastating disease, secondary only to lung and bronchus cancer in frequency and cancer deaths in women.¹ Survival rates in women with breast cancer are much higher when the cancer is detected at an early stage and this is why routine screening mammograms are recommended by the American Cancer Society for women 40 years of age and older.1,2

Screening mammography has long been the mainstay in detecting non-palpable breast cancer while it is the most curable. However, while the accuracy of mammography is high in fatty breasts, breast density is a major limitation to the sensitivity of mammographic screening, prompting researchers to look for alternative methods to improve detection in these women. Breast density is a strong independent risk factor for the development of breast cancer. In several studies, women with the highest levels of breast density were found to have a 4- to 6-fold increased risk of breast cancer compared with women with the lowest density classification .3

Breast density has also been shown to increase a women's lifetime risk for developing breast cancer. About 40% of women have some dense breast tissue, and visualization of cancers in dense breast tissue with mammography is sometimes limited.1,3,4,5 The result is missed cancers or the discovery of later-stage cancers in women which may require more aggressive treatment options.2  A more thorough screening approach may be needed for these women and the SOMO•INSIGHT clinical research study is exploring a possible solution.  

According to a peer reviewed study by Boyd et al published in the New England Journal of Medicine, "Women with dense tissue in 75% or more of the breast have a risk of breast cancer four to six times as great as the risk among women with little or no dense tissue."3 While mammography remains the gold standard for breast cancer screening, clinical studies have shown improved early detection of breast cancer when ultrasound is used as an adjunct to mammography for women with dense breast tissue.



Citation 1: American Cancer Society. Breast Cancer Facts & Figures 2011-2012

Citation 2: Duffy SW, Tabár L, et al. Cancer. 2002;458-469 

Citation 3: Boyd, et al. New England Journal of Medicine 2007;356:227-36M

Citation 4: Stone, et al. Cancer Epidemiology, Biomarkers & Prevention. 2006;612-617

Citation 5: Kolb, et al. Radiology. 1998;191-199