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 - Full Text View

Sponsor:	City of Hope Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	City of Hope Medical Center
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	Biological: therapeutic estradiol Drug: deslorelin Drug: therapeutic testosterone	Phase II

Study Type:	Interventional
Study Design:	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 ]

Estimated Enrollment:	10
Study Start Date:	February 2004
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

0.35mg/100ul per day as a nasal spray

1mg/100ul per day as a nasal spray

0.275mg/100ul per day as a nasal spray

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
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)

More Information

Additional Information:

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

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
Study First Received:	April 7, 2004
Last Updated:	October 14, 2011
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate

Deslorelin
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012