Table 1.

Key inclusion and exclusion criteria for the BIG 1-98 trial

Inclusion

Postmenopausal women with operable breast cancer ER and/or PgR ≥ 10 fmol/mg cytosol protein; or ≥ 10% of tumor cells positive by immunocytochemical evaluation Received adequate mastectomy, lumpectomy, or quadrantectomy for primary breast cancer Adequate marrow and renal function Written informed consent

Exclusion

Distant metastases Bilateral breast cancer Previous malignancy within the previous 5 years except for adequately treated basal or squamous cell carcinoma Receiving adjuvant chemotherapy at randomization Other nonmalignant systemic diseases Treatment with investigational drugs within 30 days Known HIV positive