Clinical Trial of Tamoxifen-based Gel in Reducing Breast Density Recruiting in US, EU

Clinical Trial of Tamoxifen-based Gel in Reducing Breast Density Recruiting in US, EU
The ability of a gel containing a tamoxifen-byproduct to reduce breast density — associated with an increased risk of breast cancer — is now being evaluated in a recruiting Phase 3 clinical trial. Approximately half of women in the U.S. have dense breast tissue, which has been shown to have two major health implications. First, several studies have reported that women with dense breast tissue have a four- to six-fold increased risk of developing breast cancer, compared to women with less-dense breasts. Only age and mutations in BRCA genes have a bigger influence on breast cancer risk. Second, higher breast density decreases the effectiveness of cancer detection through mammography — the standard method for breast cancer detection. Dense breast tissue can mask a tumor’s presence on a mammogram. The fact that radiologists may be less confident in judging a mammography of dense breast tissue can also lead to more false-positive diagnoses. This unnecessarily exposes patients to invasive procedures, greater stress, and higher healthcare costs. Identifying the causes of dense breast tissue and ways to possibly reduce breast density is of particular interest. Higher breast density has been associated with high levels of estrogen. Tamoxifen — an oral cancer therapy commonly used to treat and prevent some types of breast cancer by reducing estrogen levels — was shown to effectively lessen breast density. However, oral tamoxifen affects estrogen levels throughout
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