Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
This trial has been completed.
|Treatments||arzoxifene hydrochloride, tamoxifen citrate|
|Sponsor||University of Kansas Medical Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||July 2000|
|End date||August 2002|
|Trial identifier||NCT00005886, CDR0000067956, KUMC-7813-99, KUMC-HSC-7419-98, NCI-P00-0158|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||University of Alabama at Birmingham Comprehensive Cancer Center||completed|
|Los Angeles, CA||Jonsson Comprehensive Cancer Center, UCLA||completed|
|Palm Springs, CA||Comprehensive Cancer Centers of the Desert||completed|
|Maywood, IL||Loyola University Medical Center||completed|
|Kansas City, KS||University of Kansas Medical Center||completed|
|Cleveland, OH||Cleveland Clinic Taussig Cancer Center||completed|
|Columbus, OH||Arthur G. James Cancer Hospital - Ohio State University||completed|
|Philadelphia, PA||Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||completed|
|Dallas, TX||U.S. Oncology Research Inc.||completed|
Female participants from 18 years up to 120 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed noninvasive or small invasive breast cancer - Low or intermediate grade (ductal carcinoma in situ, T1, or T2) OR - Estrogen and/or progesterone receptor positive - Largest mass no greater than 5 cm - Clustered microcalcifications as only abnormality allowed with no upper size limit - If no distinction between mass and microcalcifications, size as 1 lesion - Lumpectomy or mastectomy must be planned for 2-6 weeks from start of study - No evidence of metastases from any malignancy - Hormone receptor status: - Estrogen and progesterone receptor positive (unless low or intermediate grade tumor) PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Postmenopausal by one of the following: - Prior oophorectomy - Over age 50 with prior hysterectomy, ovaries remaining - Uterus and ovaries intact and no menstrual period for more than 3 months Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 10 g/dL - Absolute granulocyte count greater than 1,000/mm^3 Hepatic: - Albumin greater than 3 g/dL - Bilirubin less than 1.5 mg/dL - AST less than 100 U/L - Alkaline phosphatase less than 200 U/L Renal: - Creatinine less than 1.5 mg/dL Cardiovascular: - No history of deep vein thrombosis Pulmonary: - No prior pulmonary embolus Other: - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 1 year since prior chemotherapy Endocrine therapy: - At least 1 year since prior aromatase inhibitors, antiestrogens, or LH agonists/antagonists - No concurrent hormone replacement therapy or oral contraceptives (from time of randomization) Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - No concurrent treatment for other malignancy
|Official title||A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer|
|Description||OBJECTIVES: - Determine whether LY353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. - Phase I: Patients are randomized to receive either oral LY353381 hydrochloride or oral placebo daily. Upon completion of phase I, all treatment centers begin phase II of the study. - Phase II: Patients are randomized to receive either oral tamoxifen or oral placebo daily. 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.|
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