CompletedPhase 4

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

Belgium33 participantsStarted 2016-02-17

Plain-language 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.

Who can participate

Age range18 Years – 30 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Does Ovitrelle result in early prevention of breast cancer in BRCA1 and BRCA2 carriers?

Timeframe: 48 weeks

Trial details

NCT IDNCT03495609

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-18

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