Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Exclusion Criteria

• •Prior hormonal therapy to treat locally recurrent, locally advanced or metastatic disease
• •Prior adjuvant therapy with aromatase inhibitors or antiestrogens/SERMs within 12 months prior to enrollment
• •Progression of disease during therapy with antiestrogens (including SERMs administered for prevention of osteoporosis)
• •Life-threatening locally recurrent, locally advanced or metastatic disease or disease requiring chemotherapeutic intervention (such as inflammatory breast cancer)
• •History of known CNS metastases, significant neurological dysfunction including active seizures, or clinical signs of other significant neurological diseases
• •Other active malignancy (except basal cell carcinoma of the skin or in situ cervical cancer). Patients with previous malignancies must be without evidence of disease for at least five years
• •Renal insufficiency (serum creatinine \> 2.0 mg/dL)
• •Aspartate aminotransferase, alanine aminotransferase or serum bilirubin levels more than 2.5 times upper limit of normal
• •Hemoglobin \<9 g/dL
• •Platelet count of less than 100,000 platelets per mm3
• •Total white blood cell count of less than 2,000 cells per mm3
• •Premenopausal endocrine status; pregnant or lactating females
• •Usage of an investigational drug within the thirty (30) days prior to enrollment; or the planned usage of an investigational drug other than the study medication during the course of the current study
• •Contraindication to use of toremifene, atamestane, letrozole or any of the inactive components of their formulations
• •Prior enrollment in this study