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

Ipsen

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Treatments

Drug: BN83495

Study type

Interventional

Funder types

Industry

Identifiers

NCT01230970

X-55-58064-005

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

Female

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

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