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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00700778
First received: June 18, 2008
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
BRCA1 Mutation
Breast Cancer
 Biological: recombinant human chorionic gonadotropin
Genetic: microarray analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: needle biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 90 days and 270 days from baseline ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: July 2008
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
 Biological: recombinant human chorionic gonadotropin Genetic: microarray analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: needle biopsy

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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700778

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Austria
Universitaetsklinik fuer Frauenheilkunde
Vienna, Austria, A-1090
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jose Russo, MD, FCAP Fox Chase Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00700778     History of Changes
Other Study ID Numbers: 06827, 06827, R21CA124522
Study First Received: June 18, 2008
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Fox Chase Cancer Center:
breast cancer
BRCA1 mutation carrier

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013