Breast Cancer
Conditions
Brief 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.
Interventions
DRUGBN83495
40mg tablet oral daily administration from Day 1 to Day 14.
Sponsors
Ipsen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intratumoural levels of sex hormones | Baseline and Day 14 |
| Intratumoural steroid sulphatase activity | Baseline and Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with complete cell cycle response, defined as Ki67 staining ≤1% | Baseline and Day 14 |
| Change in Apoptotic Index determined by M30 antibody | Baseline and Day 14 |
| Change in the intratumoural Ki67 proliferation index | Baseline and Day 14 |
| Change in steroid sulphatase activity in peripheral blood mononuclear cells (PBMCs). | Baseline and Day 14 |
| Change in Growth Index (Ki67 proliferation index/M30 apoptotic index) | Baseline and Day 14 |
| Proportion of subjects with a decrease in Ki67 staining ≥50% | Baseline and Day 14 |
Countries
Norway
Outcome results
None listed