Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers

• Status: Completed
• Trial end date: 2018-12-18
• Target enrollment: 0
• Participant gender: Female

Summary

Specific aim: To establish the proof of principle that treatment of "high breast cancer risk" women with recombinant human chorionic gonadotropin (r-hCG) will change their breast epithelium's high risk genomic profile to one similar to that identified in women with a history of early full first term pregnancy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborators: Fox Chase Cancer Center; Ziekenhuis Oost-Limburg
• Treatments: Chorionic Gonadotropin

Criteria

Inclusion Criteria:

• premenopausal women

• BRCA1 carrier

Exclusion Criteria:

• History of allergic reaction to compounds of similar chemical or biologic composition to hCG

• receiving medication that could interfere with the study protocol objectives (hormonal contraceptives, androgens, prednisone, thyroid hormones, insulin)

• previous treatment with follicle stimulating hormone for assisted reproduction

• uncontrolled intercurrent illness

• Heart disease

• Severe cognitive decline

• Psychiatric desease

• HIV positive

• Hepatitis B or C infection