NCT00005886
Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
PHASE1
COMPLETED
NCT00005886
INTERVENTIONAL
A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
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.
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
Breast Cancer
- TREATMENT
-
- Type: DRUG
- Name: arzoxifene hydrochloride
- Description:
- Arm Group Labels:
-
- Type: DRUG
- Name: tamoxifen citrate
- Description:
- Arm Group Labels:
- University of Kansas Medical Center