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

Breast Cancer Clinical Trial

Official title:

Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00080756
• Other study ID #: 02164
• Secondary ID: P30CA033572CHNMC
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 11, 2004
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed by deslorelin) may be effective in preventing breast cancer in at-risk women.

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• brca1 Mutation Carrier
• brca2 Mutation Carrier
• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• therapeutic estradiol
0.35mg/100ul per day as a nasal spray

Drug:
• deslorelin
1mg/100ul per day as a nasal spray
• therapeutic testosterone
0.275mg/100ul per day as a nasal spray

Procedure:
• therapeutic conventional surgery
Undergo risk reduction mastectomy

Other:
• active surveillance
Undergo continued surveillance

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300		Day 300
Primary	Perspectives about risk reduction options and their impact on quality of life (QOL) as assessed by Medical Outcomes 36-item short-form version, Health Perceptions scale, and Body Image scale on days 1, 169, and 300, and then every 6 months for 2 years		2 years