Trial Information

Does Tamoxifen Prevent the Skeletal and Cardiovascular Morbidity of Chemotherapy in Premenopausal Women?

OBJECTIVES:

- Compare the bone density in the femoral neck and lumbar spine and cholesterol levels in
premenopausal women with stage I or II breast cancer treated with adjuvant chemotherapy
with or without tamoxifen.

- Collect information regarding breast cancer risk factors, treatment, pathology, diet,
activity levels, weight, and smoking in these patients.

OUTLINE: Patients are stratified according to type of treatment (adjuvant chemotherapy plus
tamoxifen vs adjuvant chemotherapy alone).

Patients receive adjuvant chemotherapy with or without oral tamoxifen at the discretion of
the treating physician.

Prior to starting chemotherapy, patients undergo blood draw to measure baseline levels of
follicle-stimulating hormone, estradiol, total cholesterol, high-density lipoproteins, and
low-density lipoproteins. Patients undergo baseline bone densitometry of the femoral neck
and lumbar spine to assess bone density prior to starting chemotherapy or within 30 days of
the first drug treatment. Laboratory studies and bone densitometry are repeated at years 1
and 2. A comparison is made between the study findings at baseline and at years 1 and 2.

PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study.