Breast Cancer Clinical Trial
Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women with BRCA1 mutations.
PURPOSE: This clinical trial is studying recombinant human chorionic gonadotropin in preventing breast cancer in premenopausal women with BRCA1 mutations.
Determine whether the genomic profiles of breast epithelial cells of high-breast cancer-risk women, as defined by their positive BRCA1 status and nulliparous condition, express a signature indicative of high-risk.
Determine whether women identified to express a "high-breast cancer-risk" signature will revert it to a "low-risk" signature after a 90-day treatment with r-hCG, which should have induced breast differentiation and genomic changes that would serve as biomarkers indicative of decreased breast cancer risk.
OUTLINE: Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.
Benign breast tissue specimens are collected by core needle biopsy at baseline, day 90, and day 270. Tissue samples are analyzed by cytopathology for epithelial normality, Ki67 immunohistochemical staining for cell proliferation, cDNA microarray for gene expression, and serum studies for hormone levels and biomarker determinations.
After completion of study treatment, patients are followed for 24 weeks.
Asymptomatic women who have a deleterious mutation on the BRCA1 gene
Normal, no complaints, no evidence of disease
Nulliparous, never pregnant (G0P0)
No previous diagnosis of breast or ovarian cancer
No known brain metastases
Hormone receptor status not specified
ECOG performance status (PS) 0-1 OR Karnofsky PS 90-100%
Premenopausal with normal menstrual cycles and intact ovaries
Normal ovarian size report from pelvic ultrasound
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to human chorionic gonadotropin preparations or one of its excipients
No uncontrolled intercurrent illness including any of the following:
Ovarian enlargement of undetermined origin
Ovarian cysts > 2 cm
Microcystic ovaries, which might predispose to the development of ovarian hyperstimulation syndrome
History of prior cancer other than non-melanoma skin cancer
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Severe cognitive deficit or psychiatric illness/social situations that would make her unable to give informed consent or would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
At least 6 weeks since prior and no concurrent oral contraceptives or hormone-replacement therapy
No concurrent tamoxifen for chemoprevention
No concurrent participation in another chemopreventive trial for breast cancer
No concurrent medication that could interfere with this study including any of the following:
No other concurrent investigational agents
No recent treatment with follicle-stimulating hormone for assisted reproduction
No HIV-positive patients on concurrent combination antiretroviral therapy
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There are 3 Locations for this study
Rochester Minnesota, 55905, United States
Philadelphia Pennsylvania, 19111, United States
Vienna , A-109, Austria
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