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Genomic Markers of Breast Cancer Prevention induced by hCG in Women at High Risk

Workflow State: 
Approved
Type of proposal: 
Participant recruitment (what is this?)
Does this project have funding?: 
Yes

Researcher Information

First name: 
Irma
Last name: 
Russo
Degree: 
MD
Work phone number: 
(215) 728-4781

Institution Information

Fox Chase Cancer Center
333 Cottman Avenue
19111 Philadelphia , PA
United States

Project Information

Number of Participants Needed: 
18
Inclusion and Exclusion Criteria: 
1. INCLUSION CRITERIA 1.1. Asymptomatic women of all racial and ethnic groups carriers of a deleterious mutation on the BRCA1 gene, as determined by testing in a CLIA-certified clinical genetics laboratory. 1.2. ECOG performance status 0 (Karnofsky 100%). 1.3. No clinical evidence of disease. 1.4. Premenopausal women between the ages of 20-40 having normal menstrual cycles and intact ovaries. 1.5. Nulligravida, never pregnant (G0P0). 1.6. Not on oral contraceptives or hormone replacement therapy, and if taking them, stopping six weeks prior to the initiation of treatment and the performance of the first core needle biopsy (CNB) and blood drawing. 1.7. Currently not participating in a chemopreventive trial for breast cancer. 1.8. Currently not taking tamoxifen for chemoprevention. 1.9. No history of prior cancer other than non-melanoma skin cancer, 1.10. Normal ovarian size report from pelvic ultrasound. 1.11. Ability to understand and the willingness to sign a written informed consent document. 1.12. Willing to self-administer or to get the recombinant human chorionic gonadotropin administered by partner for three months and to return for two repeat core needle biopsy (CNB). 1.13. The effects of recombinant human chorionic gonadotropin on the developing human fetus are unknown. Human chorionic gonadotropin is highly elevated in the serum of pregnant women, therefore is not expected to be teratogenic. Nevertheless, women of child-bearing potential must agree to use adequate contraception, including barrier method of birth control, abstinence or tubal ligation performed prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 2. EXCLUSION CRITERIA 2.1.1. Participants may not be receiving any other investigational agents. 2.1.2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to human chorionic gonadotropin preparations or one of its excipients. 2.1.3. Participants receiving medications that could interfere with the study protocol such as hormonal contraceptives, androgens, prednisone, thyroid hormones, or insulin 2.1.4. Previous treatment with follicle stimulating hormone for assisted reproduction Uncontrolled intercurrent illness including, but not limited to ovarian enlargement of undetermined origin at the time of admission, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, severe cognitive deficit or psychiatric illness/social situations that would make her unable to give informed consent or would limit compliance with study requirements. 2.1.5. HIV-positive participants receiving combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with recombinant human chorionic gonadotropin. 2.2. INCLUSION OF WOMEN AND MINORITIES Only women members of all races and ethnic groups are eligible for this trial. Men are not included in these studies due to the low absolute risk of breast cancer and to the difficulty of performing core needle biopsy on the male breast.

Project Details

IRB Approval: 
Yes
Legacy Date Received: 
2010-01-19 14:26:15