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Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations

Information source: Fox Chase Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: BRCA1 Mutation; Breast Cancer

Intervention: recombinant human chorionic gonadotropin (Biological); microarray analysis (Genetic); immunohistochemistry staining method (Other); laboratory biomarker analysis (Other); needle biopsy (Procedure)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Fox Chase Cancer Center

Official(s) and/or principal investigator(s):
Jose Russo, MD, FCAP, Principal Investigator, Affiliation: Fox Chase Cancer Center

Summary

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.

Clinical Details

Official title: Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Measurement of gene expression in breast epithelial cells obtained for asymptomatic high breast cancer risk nulliparous premenopausal women at baseline, after treatment with r-hCG at 90 days, and at 270 days from baseline

Detailed description: OBJECTIVES: Primary

- 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. Secondary

- 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.

Eligibility

Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

- 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 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:

- Hormonal contraceptives

- Androgens

- Prednisone

- Thyroid hormones

- Insulin

- No other concurrent investigational agents

- No recent treatment with follicle-stimulating hormone for assisted reproduction

- No HIV-positive patients on concurrent combination antiretroviral therapy

Locations and Contacts

Universitaetsklinik fuer Frauenheilkunde, Vienna A-1090, Austria

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania 19111-2497, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2008
Last updated: January 22, 2015

Page last updated: August 23, 2015

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