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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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008

Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00080756
  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
Drug: deslorelin
Drug: therapeutic estradiol
Drug: therapeutic testosterone
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

Drug Information available for:   Testosterone    Methyltestosterone    Oxymesterone    Testosterone enanthate    Testosterone Propionate    Testosterone undecanoate    Depogen    Estradiol    Estradiol 3-benzoate    Estradiol acetate    Estradiol cypionate    Estradiol dipropionate    Estradiol valerate    Polyestradiol phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention
Official Title:   Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers

Further study details as provided by National Cancer Institute (NCI):

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 [ 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 [ Designated as safety issue: No ]

Estimated Enrollment:   10
Study Start Date:   February 2004
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine the effects of deslorelin in combination with low-dose add-back estradiol and testosterone on the breast of premenopausal women with or without a BRCA gene mutation who are at high risk for breast cancer.
  • Correlate changes in mammographic and MRI densities with tissue morphometrics and biomarkers in participants treated with this regimen.
  • Determine cell proliferation and changes in estrogen receptor, progesterone receptor, or aromatase expression in participants treated with this regimen.
  • Determine perspectives about risk reduction options in participants treated with this regimen.
  • Determine the impact of this regimen on the quality of life of these participants.
  • Analyze the expression of BRCA1 and BRCA2 in breast tissue of these participants before and after treatment with this regimen.

OUTLINE: This is a pilot study.

Participants receive intranasal deslorelin, estradiol, and testosterone once daily for 6-10 months.

Quality of life is assessed at baseline, at 6 and 10 months, and then every 6 months until 2 years after study registration.

PROJECTED ACCRUAL: A total of 10 participants will be accrued for this study.

  Eligibility
Ages Eligible for Study:   21 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

DISEASE CHARACTERISTICS:

  • Known high risk of breast cancer due to a BRCA gene mutation OR empiric risk > 30% lifetime by the Claus model
  • No immeasurable breast density on mammogram (BIRADS 1)
  • Meets criteria for 1 of the following:

    • Planning a risk-reduction mastectomy in 6 months or more
    • Planning to continue surveillance
  • Hormone receptor status:

    • Not applicable

PATIENT CHARACTERISTICS:

Age

  • 21 to 48

Sex

  • Female

Menopausal status

  • Premenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Hematopoietic function within normal limits

Hepatic

  • Hepatic function within normal limits

Renal

  • Renal function within normal limits

Other

  • In generally good health with normal laboratory values and physical examination
  • Not pregnant or nursing

    • No pregnancy or nursing within the past 6 months
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal barrier contraception
  • Non-smoker
  • No prior or suspected malignancy except nonmelanoma skin cancer
  • No nasal polyposis
  • No atrophic, severe allergic, or vasomotor rhinitis
  • No sinusitis requiring current treatment or treatment for more than 3 months in the past year

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • More than 1 year since prior gonadotropin-releasing hormone agonist therapy
  • At least 6 months since prior implanted or injected contraceptives
  • No concurrent corticosteroids
  • No other concurrent estrogens, progestins, or androgens, including oral, implanted, or injected contraceptives

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  Contacts and Locations

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

Locations
United States, California
City of Hope Comprehensive Cancer Center     Recruiting
      Duarte, California, United States, 91010-3000
      Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
USC/Norris Comprehensive Cancer Center and Hospital     Recruiting
      Los Angeles, California, United States, 90089-9181
      Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente     323-865-0451        

Sponsors and Collaborators
Beckman Research Institute
National Cancer Institute (NCI)
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000355156, CHNMC-IRB-02164
First Received:   April 7, 2004
Last Updated:   August 29, 2008
ClinicalTrials.gov Identifier:   NCT00080756
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
breast cancer  
BRCA1 mutation carrier  
BRCA2 mutation carrier  

Study placed in the following topic categories:
Skin Diseases
Benzoates
Estradiol valerate
Breast Neoplasms
Methyltestosterone
Estradiol 17 beta-cypionate
Estradiol
Testosterone 17 beta-cypionate
Deslorelin
Testosterone
Estradiol 3-benzoate
Polyestradiol phosphate
Breast Diseases

Additional relevant MeSH terms:
Estrogens
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Reproductive Control Agents
Hormones
Pharmacologic Actions
Neoplasms
Anabolic Agents
Neoplasms by Site
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on November 19, 2008




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