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Project Title Genomic Markers of Breast Cancer Prevention Induced by hCG in Women at High Risk

Researcher Irma Russo, MD, Fox Chase Cancer Center, Philadelphia, Pennsylvania

Study Summary Because pregnancy and breastfeeding appear to reduce breast cancer risk in women, including those with a BRCA1 or 2 mutation, researchers are interested in seeing if giving hormones that mimic pregnancy can change these high risk women’s breast tissue in ways that appear to reduce their risk.

The researchers are looking for 18 women for this study.

Who Can Participate? You can join the GEMCP Study if you match ALL of these MAIN categories:
• Have tested positive for a BRCA1 or 2 mutation
• You live near Fox Chase Cancer Center in Philadelphia, OR Mayo Clinic in Rochester, Minnesota OR University of Texas Southwestern Medical Center in Dallas, Texas
• Have not had cancer [including DCIS. Cancer of the skin is OK (squamous or basal cell carcinoma)]
• Are between 20 and 40 years old
• Have never been pregnant
• Have both your ovaries and have regular menstrual cycles
• Are not on tamoxifen or raloxifene (Evista) or participating in the STAR study
• Are not taking the birth control pill or menopausal hormone therapy
• Have not had any form of breast surgery to make your breasts smaller or larger

What Does Participation Involve? If you sign up for the Genomic Markers of Breast Cancer Prevention Induced by hCG in Women at High Risk study (GEMCP), you will have your height and weight recorded, be asked to give a blood sample so that your hormone levels can be measured, and be asked to have an abdominal ultrasound to measure the size of your ovaries. If you are accepted into the study you will be taught how to inject yourself under the skin of your stomach with a recombinant form of human chorionic gonadotropin (r-hCG), a hormone that is released by the placenta and has been shown to reduce breast cancer risk in laboratory studies. You will be asked to inject yourself three times a week for 12 weeks. Before the study begins and two times after you have finished taking the r-hCG, you will be asked to give a blood sample. At these three visits, the researchers will also use a thin needle to take a sample of your breast tissue. In addition, before the start of the study you will be asked to fill out a questionnaire. During the 12 weeks you are on the r-hCG, you will also be asked to record any symptopms you may experience, weigh yourself weekly, and chart the start and end dats of your period.

Please note: getting tested for a BRCA1 or 2 mutation is a personal choice that should be made with your doctor. We are not recommending that you get tested in order to participate in this study.

Where? Fox Chase Cancer Center, Philadelphia, PA; Mayo Clinic, Rochester, MN; and University of Southern Texas Southwestern Medical Center, Dallas, TX