Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease
NCT ID: NCT00080756
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
11 participants
INTERVENTIONAL
2004-03-11
2024-10-15
Brief Summary
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PURPOSE: This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Group 1 (planned risk reduction mastectomy)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
therapeutic estradiol
0.35mg/100ul per day as a nasal spray
deslorelin
1mg/100ul per day as a nasal spray
therapeutic testosterone
0.275mg/100ul per day as a nasal spray
therapeutic conventional surgery
Undergo risk reduction mastectomy
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Group 2 (continued survaillance)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
therapeutic estradiol
0.35mg/100ul per day as a nasal spray
deslorelin
1mg/100ul per day as a nasal spray
therapeutic testosterone
0.275mg/100ul per day as a nasal spray
active surveillance
Undergo continued surveillance
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Interventions
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therapeutic estradiol
0.35mg/100ul per day as a nasal spray
deslorelin
1mg/100ul per day as a nasal spray
therapeutic testosterone
0.275mg/100ul per day as a nasal spray
therapeutic conventional surgery
Undergo risk reduction mastectomy
active surveillance
Undergo continued surveillance
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
48 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Weitzel, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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CHNMC-IRB-02164
Identifier Type: -
Identifier Source: secondary_id
CDR0000355156
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2011-00975
Identifier Type: REGISTRY
Identifier Source: secondary_id
02164
Identifier Type: -
Identifier Source: org_study_id
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