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Feasibility Study: Breast Tissue Effects of Hormonal Contraceptive Formulations

Anne Zeleniuch-Jacquotte, MD, MS, and Tess Clendenen, PhD, New York University Medical Center, NY
Study abstract

MRI characteristics, such as the volume and percent of fibroglandular tissue (FGT), the apparent diffusion coefficient (ADC), and background parenchymal enhancement (BPE), have been shown to be hormonally responsive, including during the natural menstrual cycle, by our group and others. MRI FGT and BPE measures were also associated with an increased risk of breast cancer in a small retrospective study. Long-term, this research team would like to evaluate the utility of these MRI measures for examining the effects of different hormonal contraceptive formulations on the breast tissue and infer their potential impact on breast cancer risk. Breast tissue biopsies collected concurrently with MRI can provide information about the effect of OCs on molecular characteristics in the breast tissue that are known to be associated with risk (e.g. breast cell proliferation and expression of genes involved in breast cancer).

Study review

The purpose of this study was to determine if there are enough eligible and willing volunteers in the New York Metro Area to conduct a larger study on the effects of various hormonal birth control formulations on breast tissue. The researchers wanted to enroll up to 1,000 volunteers from the Army of Women (AOW) from the New York Metro Area. The Call to Action for this study was sent to AOW members on October 7, 2015. The researchers closed enrollment on December 20, 2016, after the AOW provided them with 157 women who were interested in enrolling in the study.