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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: | NCT00005886 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.
PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue, compared with LY353381, in treating women with newly diagnosed breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: arzoxifene hydrochloride Drug: tamoxifen citrate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer |
Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
Upon completion of phase I, all treatment centers begin phase II of the study.
Treatment in both phases continues for 2-6 weeks (until scheduled lumpectomy or mastectomy) in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 and 2 weeks after surgery.
PROJECTED ACCRUAL: A minimum of 120 patients (60 per treatment phase) will be accrued for this study within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed noninvasive or small invasive breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Postmenopausal by one of the following:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294-3300 | |
United States, California | |
Comprehensive Cancer Centers of the Desert | |
Palm Springs, California, United States, 92262 | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1781 | |
United States, Illinois | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160-7357 | |
United States, Ohio | |
Arthur G. James Cancer Hospital - Ohio State University | |
Columbus, Ohio, United States, 43210-1240 | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
Philadelphia, Pennsylvania, United States, 19107-5541 | |
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: | CDR0000067956, KUMC-7813-99, KUMC-HSC-7419-98, NCI-P00-0158 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005886 History of Changes |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer ductal breast carcinoma in situ breast cancer in situ |
Estrogen Antagonists Estrogens Skin Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Citric Acid Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Hormones Tamoxifen Carcinoma Estrogen Receptor Modulators Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Breast Diseases |
Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases |