This trial has been completed.

Condition breast cancer
Treatments arzoxifene hydrochloride, tamoxifen citrate
Phase phase 1
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

Study Design

Allocation randomized
Primary purpose treatment
Masking double-blind

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.