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

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	Biological: therapeutic estradiol Drug: deslorelin Drug: therapeutic testosterone	Phase II

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

Resource links provided by NLM:

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

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 Comprehensive Cancer Center ( Jeffrey N. Weitzel )
Study ID Numbers:	CDR0000355156, CHNMC-IRB-02164
Study First Received:	April 7, 2004
Last Updated:	June 30, 2009
ClinicalTrials.gov Identifier:	NCT00080756 History of Changes
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:

Estrogens
Antineoplastic Agents, Hormonal
Skin Diseases
Contraceptive Agents
Benzoates
Hormone Antagonists
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Methyltestosterone

Estradiol 17 beta-cypionate
Hormones
Estradiol
Testosterone 17 beta-cypionate
Deslorelin
Anabolic Agents
Testosterone
Estradiol 3-benzoate
Polyestradiol phosphate
Breast Diseases
Androgens

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Estradiol 17 beta-cypionate
Hormones
Neoplasms by Site
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate
Breast Diseases

Estrogens
Skin Diseases
Antineoplastic Agents, Hormonal
Breast Neoplasms
Enzyme Inhibitors
Methyltestosterone
Estradiol
Pharmacologic Actions
Testosterone 17 beta-cypionate
Deslorelin
Testosterone
Neoplasms
Anabolic Agents
Androgens

ClinicalTrials.gov processed this record on September 10, 2009