Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
therapeutic estradiol
+ deslorelin
+ therapeutic testosterone
Breast Diseases+2
+ Breast Neoplasms
+ Neoplasms
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.11 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Inclusion Criteria: * 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) * Prior tubal ligation or willing to use a non-hormonal barrier method of contraception * Signed the Informed Consent Form document for this study in accordance with all Federal, State and Institutional regulations * Must be current non-smoker Exclusion Criteria: * 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 * Immeasurable breast density on mammogram
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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