Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Fox Chase Cancer Center - Philadelphia

Jose Russo

Principal Investigator

U.S.A.
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Sandhya Pruthi, MD	Ph: 507-538-0289
Pennsylvania
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Jose Russo	Ph: 215-728-4782
			Email: Jose.Russo@fccc.edu
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center a	Ph: 866-460-4673; 214-648-7097
Austria
	Vienna
	Universitaetsklinik fuer Frauenheilkunde
		Georg Pfeiler, MD	Ph: 43-1-40-400-2801

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00700778
Information obtained from ClinicalTrials.gov on September 25, 2012

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