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Sponsors and Collaborators: |
University of Kansas National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005879 |
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: arzoxifene hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control |
Official Title: | A Phase II Clinical Trial of a Selective Estrogen Receptor Modulator (LY353381*HCl) in High Risk Women With Fine Needle Aspiration Cytologic Evidence of Hyperplasia |
Study Start Date: | August 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, multicenter study followed by an open-label study for both arms. Patients are stratified according to cytologic status (hyperplasia with atypia vs hyperplasia without atypia), mutation status (known carrier for BRCA1 or BRCA2 genes vs known not to be a carrier of mutant genes), menopausal status (premenopausal vs postmenopausal), estrogen-receptor status, and participating center. Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline and then at 6 and 12 months.
Patients are followed at 2 weeks and then annually for 5 years.
PROJECTED ACCRUAL: A total of 210-220 patients will be accrued for this study within 2.5-3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Current random fine needle breast aspiration (FNA) evidence of 1 of the following:
Classified as ACR class I-III on mammogram with stepwedge within past 6 months If intact uterus and/or ovaries, must have color doppler transvaginal pelvic sonogram within past 6 months showing endometrial thickening no greater than 13 mm premenopausal or no greater than 8 mm postmenopausal
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160-7820 | |
United States, Texas | |
U.S. Oncology Research, Inc. | |
Dallas, Texas, United States, 75246 |
Study Chair: | Carol J. Fabian, MD | University of Kansas |
Study ID Numbers: | CDR0000067918, KUMC-HSC-7264-97, NCI-P00-0146 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005879 History of Changes |
Health Authority: | United States: Federal Government |
breast cancer |
Estrogen Receptor Modulators Estrogens Hyperplasia Skin Diseases Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Selective Estrogen Receptor Modulators Hormones Breast Diseases |
Skin Diseases Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Selective Estrogen Receptor Modulators Pharmacologic Actions |
Estrogen Receptor Modulators Hyperplasia Neoplasms Neoplasms by Site Pathologic Processes Breast Diseases |