Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer

University of Kansas Medical Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Breast Cancer

Interventions

arzoxifene hydrochlorideDRUG

tamoxifen citrateDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (9)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Comprehensive Cancer Centers of the Desert

Palm Springs, California, United States

Data from ClinicalTrials.gov

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