Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 in Postmenopausal Women With Newly Diagnosed Breast Cancer

Inclusion Criteria

• •Female subjects 55 to 80 years with histologically or cytologically documented primary intraductal or lobular invasive breast cancer that meets the following criteria:
• •T2, N0 or N1, M0.
• •Primary tumour clinically determined to be 2 to 5 cm in the greatest dimension.
• •Laboratory documentation of positive oestrogen receptor (ER+) status in at least 10% of the tumour cells.
• •Laboratory documentation of HER-2 negative status.
• •Postmenopausal defined as
• •no spontaneous menses for a total of 2 years
• •amenorrheic for at least 12 months with serum oestrogen level \<30 pg/mL, and both luteinising hormone (LH)/follicle stimulating hormone (FSH) \>20 IU/L, chemotherapy-induced amenorrhoea for at least 12 months
• •bilateral oophorectomy, or radiation castration and amenorrhoeic for at least 3 months.
• •Eastern Cooperative Oncology Group (ECOG) performance status ≤2.