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Status:

TERMINATED

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

Lead Sponsor:

Fox Chase Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

BRCA1 Mutation

Breast Cancer

Eligibility:

FEMALE

20-40 years

Phase:

NA

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 muta...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2014

    Estimated Enrollment :

    2 Patients enrolled

    Trial Details

    Trial ID

    NCT00700778

    Start Date

    July 1 2008

    End Date

    March 1 2014

    Last Update

    January 25 2021

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Mayo Clinic Cancer Center

    Rochester, Minnesota, United States, 55905

    2

    Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, United States, 19111-2497

    3

    Universitaetsklinik fuer Frauenheilkunde

    Vienna, Austria, A-1090