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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

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ClinicalTrials.gov Identifier: NCT00080756
Recruitment Status : Active, not recruiting
First Posted : April 8, 2004
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief 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.


Condition or disease Intervention/treatment 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

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  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
Actual Study Start Date : March 11, 2004
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Deslorelin

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.
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   21 Years to 48 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeffrey Weitzel, MD City of Hope Medical Center

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00080756     History of Changes
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 )
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

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

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