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 ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

City of Hope Medical Center

ClinicalTrials.gov Identifier:

NCT00080756

First received: April 7, 2004

Last updated: October 14, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 7, 2004
Last Updated Date	October 14, 2011
Start Date ^ICMJE	February 2004
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 12, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: November 8, 2006)	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 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
Change History	Complete list of historical versions of study NCT00080756 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers
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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	brca1 Mutation Carrier brca2 Mutation Carrier Breast Cancer
Intervention ^ICMJE	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
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	10
Completion Date
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	21 Years to 48 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00080756
Other Study ID Numbers ^ICMJE	02164, P30CA033572, CHNMC-IRB-02164, CDR0000355156
Has Data Monitoring Committee	No
Responsible Party	City of Hope Medical Center
Study Sponsor ^ICMJE	City of Hope Medical Center
Collaborators ^ICMJE	National Cancer Institute (NCI)
Investigators ^ICMJE
Information Provided By	City of Hope Medical Center
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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