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

NCT ID: NCT00700778

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2014-03-31

Brief 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.

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.

Conditions

BRCA1 Mutation; Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Recombinant human chorionic gonadotropin

Patients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity.

Group Type: EXPERIMENTAL

recombinant human chorionic gonadotropin

Intervention Type: BIOLOGICAL

microarray analysis

Intervention Type: GENETIC

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

needle biopsy

Intervention Type: PROCEDURE

Interventions

recombinant human chorionic gonadotropin

Intervention Type: BIOLOGICAL

microarray analysis

Intervention Type: GENETIC

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

needle biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Russo, MD, FCAP

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Universitaetsklinik fuer Frauenheilkunde

Vienna, , Austria

Countries

United States; Austria

Other Identifiers

06827

Identifier Type: OTHER

Identifier Source: secondary_id

R21CA124522

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06827

Identifier Type: -

Identifier Source: org_study_id