Skip to content

Trial · Interventional

TerminatedNot applicableResults postedRegistry data

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

NCTNCT00700778 (opens ClinicalTrials.gov in a new tab)Other id06827Other id06827Other idR21CA124522
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Not applicable
Enrollment
2 participants (actual)
Sponsor
Fox Chase Cancer Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

United States, Austria

Start
Jul 2008
Primary completion
Mar 2014
Completion
Mar 2014
First posted
19 Jun 2008 (estimated)
Last update posted
25 Jan 2021
Conditions
BRCA1 Mutation · Breast Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008201020122014
  1. N/A

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

    NCT00700778

    Jul 2008 to Mar 2014

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • recombinant human chorionic gonadotropinBiological
  • microarray analysisGenetic
  • immunohistochemistry staining methodOther
  • laboratory biomarker analysisOther
  • needle biopsyProcedure

Arms1

  • Experimental

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Time frame · 90 days and 270 days from baseline

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 90 days and 270 days from baseline

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

GroupValue
Recombinant Human Chorionic Gonadotropinnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Recombinant Human Chorionic GonadotropinPatients receive recombinant human chorionic gonadotropin subcutaneously three times weekly. Treatment continues weekly for 90 days in the absence of unacceptable toxicity. recombinant human chorionic gonadotropin microarray analysis immunohistochemistry staining method laboratory biomarker analysis needle biopsy0 / 20 / 20 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.