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

August 26, 2024 updated by: City of Hope Medical Center

Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (planned risk reduction mastectomy)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 6 months. Patients then undergo planned risk reduction mastectomy.
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Biological: therapeutic estradiol
0.35mg/100ul per day as a nasal spray
Drug: deslorelin
1mg/100ul per day as a nasal spray
Drug: therapeutic testosterone
0.275mg/100ul per day as a nasal spray
Procedure: therapeutic conventional surgery
Undergo risk reduction mastectomy
Active Comparator: Group 2 (continued survaillance)
Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Biological: therapeutic estradiol
0.35mg/100ul per day as a nasal spray
Drug: deslorelin
1mg/100ul per day as a nasal spray
Drug: therapeutic testosterone
0.275mg/100ul per day as a nasal spray
Other: active surveillance
Undergo continued surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Day 300
Day 300
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
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jeffrey Weitzel, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2004

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

October 15, 2024

Study Registration Dates

First Submitted

April 7, 2004

First Submitted That Met QC Criteria

April 7, 2004

First Posted (Estimated)

April 8, 2004

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02164
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-IRB-02164
  • CDR0000355156 (Registry Identifier: NCI PDQ)
  • NCI-2011-00975 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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