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Genomic Markers of Breast Cancer Prevention Induced by hCG in Women at High Risk study (GEMCP)

Irma Russo, MD, and Jose Russo, MD, Fox Chase Cancer Center, Philadelphia, PA
Study abstract

This study will test the hypothesis that the genomic profile of breast epithelial cells of asymptomatic nulliparous women carriers of BRCA1 germline mutations is characteristic of such a risk, and that the induction of differentiation by treatment with human chorionic gonadotropin (r-hCG) would revert the “high risk” to a “low risk” signature that would serve as a biomarker indicative of decreased breast cancer risk. Breast epithelial cells will be collected by random periareolar fine needle aspiration from women with BRCA1 mutations. Cells will be cytopathologically evaluated; RNA will be extracted for analysis of gene expression by cDNA microarray, and immunocytochemical determination of cell proliferation by Ki67, ER and PR status, parameters that will serve as a baseline of the “high risk” genomic profile. This knowledge will serve as the basis for establishing novel genomic signatures as intermediate biomarkers for larger preventive clinical trials at the completion of this project.

Study review

This study at Fox Chase Cancer Center in Philadelphia, PA, is investigating whether giving hormones that mimic pregnancy to women with a BRCA1 or 2 mutation can change these high risk women’s breast tissue in ways that appear to reduce their risk. The researchers wanted to enroll 11 Army of Women members. The Call to Action for this study was sent to Army of Women members on April 14, 2010. The researchers closed enrollment on March 19, 2013, after the Army of Women provided them with 7 women who were interested in enrolling in the study.