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

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas; University of Kansas Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Tamoxifen

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