ZK 230211 in Postmenopausal Woman With Metastatic Breast Cancer

Inclusion Criteria

• •Postmenopausal women defined as: aged \>/= 50 years with amenorrhea for at least 12 months or aged \< 50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (\> 40 mIU/ml) or having undergone bilateral oophorectomy
• •Histologically or cytologically confirmed breast cancer
• •Metastatic breast cancer (Stage IV according to UICC - Union Internationale Contre Cancer - criteria, Version 6)
• •Progesterone receptor-positive tumors
• •Patients must be considered candidates for endocrine therapy (no other therapies for breast cancer are required)
• •Disease progression after first-line endocrine therapy for advanced breast cancer (i.e. with tumor remission or stabilization lasting at least 3 months under endocrine therapy)
• •At least one measurable or non-measurable tumor lesion (according to RECIST criteria)
• •WHO Performance status 1
• •Adequate function of major organs and systems:
• •* Hematopoietic:
• •* Hemoglobin: 10 g/dL
• •* Absolute neutrophil count: 1,500/mm3
• •* Platelet count: 100,000/mm3
• •* Hepatic:
• •* Total bilirubin: 1.5 times the upper limit of normal
• •* AST/ALT: 2.5 times the upper limit of normal
• •* Renal: Creatinine: 1.5 times the upper limit of normal
• •* Gynecological: Endometrial thickness (in non-hysterectomized women) \</= 10 mm double layer
• •* No other uncontrolled concurrent illness
• •Adequate recovery from previous surgery, radiation and chemotherapy
• •Written informed consent