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

• Sponsor: Fox Chase Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00700778
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 2
• Locations: 3
• Arm: 1
• Duration (Months): 68
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
BRCA1 Mutation; Breast Cancer	Biological: recombinant human chorionic gonadotropin; Genetic: microarray analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: needle biopsy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.	Biological: recombinant human chorionic gonadotropin; Genetic: microarray analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: needle biopsy

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

• Fox Chase Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jose Russo, MD, FCAP, Fox Chase Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fox Chase Cancer Center
• ClinicalTrials.gov Identifier: NCT00700778
• Other Study ID Numbers: 06827; 06827; R21CA124522
• First Posted: Jun 19, 2008
• Last Update Posted: Jan 25, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Fox Chase Cancer Center: breast cancer; BRCA1 mutation carrier
• Additional relevant MeSH terms: Breast Neoplasms; Chorionic Gonadotropin

Study Results

Participant Flow

Arm/Group Title	Recombinant Human Chorionic Gonadotropin
Arm/Group Description	Patients 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 biopsy
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Recombinant Human Chorionic Gonadotropin
Arm/Group Description	Patients 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 biopsy
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Region of Enrollment (participants) [Number]
Austria	1 50%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

No results were obtained

Arm/Group Title	Recombinant Human Chorionic Gonadotropin
Arm/Group Description	Patients 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 biopsy
Measure Participants	0

Adverse Events

Arm/Group Title	Recombinant Human Chorionic Gonadotropin
Arm/Group Description	Patients 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 biopsy
All Cause Mortality
	Recombinant Human Chorionic Gonadotropin
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Recombinant Human Chorionic Gonadotropin
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Recombinant Human Chorionic Gonadotropin
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.