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

Study Overview
=================
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.

Official Title
-----------------
A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: arzoxifene hydrochloride
* Drug: tamoxifen citrate


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: arzoxifene hydrochloride|nan|
|Drug: tamoxifen citrate|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I breast cancer, stage II breast cancer, ductal breast carcinoma in situ, breast cancer in situ