Suspended

Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers

What is being tested

therapeutic estradiol

+ deslorelin

+ therapeutic testosterone

BiologicalDrugProcedureOther

Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

From 21 to 48 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 2

Interventional

Study Start: March 2004

See protocol details

Summary

Principal SponsorCity of Hope Medical Center

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 11, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist (GnRHA)-based regimen in breast cancer (BRCA) gene mutation carriers, including correlation of changes in mammographic and magnetic resonance imaging (MRI) densities with tissue morphometrics and biomarkers. II. Evaluate perspectives about risk reduction options and impact on quality-of-life (QOL) measures of participation in the chemopreventive protocol and in risk reduction surgery. OUTLINE: GROUP 1: Patients receive deslorelin, estradiol, and testosterone intranasally once daily (QD) for 6 months. Patients then undergo planned risk reduction mastectomy. GROUP 2: Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months. After completion of study treatment, patients are followed up every 6 months for 2 years.

Official TitleBiomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers

NCT00080756

Principal SponsorCity of Hope Medical Center

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 21 to 48 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

7 inclusion criteria required to participate

Patients must generally be in good health with lab values and physical examination within normal limits

Known high risk of breast cancer due to BRCA mutation or empiric risk > 30% lifetime by the Claus model

No evidence or history of pervious cancer, except non-melanoma skin cancer

Premenopausal women planning risk reduction mastectomy in 6 months or more (Group 1) or continued surveillance (Group 2)

Show More Criteria

5 exclusion criteria prevent from participating

GnRHA treatment within 12 months of study entry

Nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year

Concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, Decadron, Deltasone, hydrocortisone, Hydrocortone, Medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (At least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as Norplant)

Pregnant or breast-feeding or have been so in the last six months

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.

Group II

Active Comparator

Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

City of Hope Medical Center

Duarte, United StatesOpen City of Hope Medical Center in Google Maps

SuspendedOne Study Center