Breast Cancer
Conditions
Keywords
stage I breast cancer, stage II breast cancer, ductal breast carcinoma in situ, breast cancer in situ
Brief summary
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.
Detailed 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.
Interventions
DRUGtamoxifen citrate
Sponsors
National Cancer Institute (NCI)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed