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

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

This trial will assess the intratumoural pharmacological activity of BN83495 by changes in intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (STS) activity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen

Criteria

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.

Exclusion Criteria:

• Has locally advanced breast cancer that is considered non-operable without neoadjuvant therapy.

• Has evidence of metastatic disease

• as a diagnosis of inflammatory breast cancer

• Has ductal carcinoma in situ