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

NCT00700778 | Terminated Results

• 2 other identifiers: 06827R21CA124522
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 3

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.

Conditions

BRCA1 Mutation; Breast Cancer

Keywords

breast cancer; BRCA1 mutation carrier

Outcome Measures

Primary Outcomes (1)

• 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

  90 days and 270 days from baseline

Study Arms (1)

Recombinant human chorionic gonadotropin

EXPERIMENTAL

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

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

Interventions

recombinant human chorionic gonadotropin BIOLOGICAL

Recombinant human chorionic gonadotropin

microarray analysis GENETIC

Recombinant human chorionic gonadotropin

immunohistochemistry staining method OTHER

Recombinant human chorionic gonadotropin

laboratory biomarker analysis OTHER

Recombinant human chorionic gonadotropin

needle biopsy PROCEDURE

Recombinant human chorionic gonadotropin

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Universitaetsklinik fuer Frauenheilkunde

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chorionic Gonadotropin; Microarray Analysis; Immunohistochemistry; Biopsy, Needle

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Microchip Analytical Procedures; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Biopsy; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures

Results Point of Contact

• Title: Dr. Jose Russo
• Organization: Fox Chase Cancer Center

Jose.Russo@fccc.edu

215-728-4782

Study Officials

• Jose Russo, MD, FCAP

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 25, 2021
• Results First Posted: January 25, 2021

Record last verified: 2021-01

Locations

US (2); AU (1)