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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00080756
First received: April 7, 2004
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
brca1 Mutation Carrier
brca2 Mutation Carrier
Breast Cancer
Biological: therapeutic estradiol
Drug: deslorelin
Drug: therapeutic testosterone
Procedure: therapeutic conventional surgery
Other: active surveillance
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: February 2004
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Procedure: quality-of-life assessment
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies
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.
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
Procedure: quality-of-life assessment
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   21 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080756

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Jeffrey Weitzel, MD City of Hope Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00080756     History of Changes
Other Study ID Numbers: 02164, P30CA033572, CHNMC-IRB-02164, CDR0000355156, NCI-2011-00975
Study First Received: April 7, 2004
Last Updated: January 21, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
breast cancer
BRCA1 mutation carrier
BRCA2 mutation carrier

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Deslorelin
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Methyltestosterone
Polyestradiol phosphate
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Enzyme Inhibitors
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 03, 2015