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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like 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. 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 Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects typically obtain the finest healthcare available for their 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 condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > 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 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
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
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): Beckman Research Institute , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of combining deslorelin with low-dose estradiol and testosterone in preventing breast cancer in premenopausal women who are at high risk for this disease.
Details: 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:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 21 Years/48 Years
Genders: Both
Protocol Entry 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 specified PATIENT CHARACTERISTICS: Age - 21 to 48 Sex - Female Menopausal status - Premenopausal Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyWeitzel, Principal Investigator, Beckman Research Institute
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010
United States
Recruiting Jeffrey Weitzel 626-256-8662
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Michael Press 323-865-0563
Additional Information:
Study ID Numbers: CDR0000355156; CHNMC-IRB-02164
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080756
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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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