A Phase II, Open-label, Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 Administered for 14 Days Prior to Surgery to Postmenopausal Women With Newly Diagnosed Primary Invasive Oestrogen Receptor Positive Breast Cancer
- Female subjects 55 to 80 years with histologically or cytologically documented
primary intraductal or lobular invasive breast cancer that meets the following
- 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
Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Has locally advanced breast cancer that is considered non-operable without
- Has evidence of metastatic disease
- as a diagnosis of inflammatory breast cancer
- Has ductal carcinoma in situ