Clinical trial NCT01230970: Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 in Postmenopausal Women With Newly Diagnosed Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2010-10-29
Enrollment: 2
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Intratumoural levels of sex hormones
timeFrame: Baseline and Day 14
measure: Intratumoural steroid sulphatase activity
timeFrame: Baseline and Day 14
Secondary outcomes:
measure: Change in the intratumoural Ki67 proliferation index
timeFrame: Baseline and Day 14
measure: Proportion of subjects with a decrease in Ki67 staining ≥50%
timeFrame: Baseline and Day 14
measure: Proportion of subjects with complete cell cycle response, defined as Ki67 staining ≤1%
timeFrame: Baseline and Day 14
measure: Change in Apoptotic Index determined by M30 antibody
timeFrame: Baseline and Day 14
measure: Change in Growth Index (Ki67 proliferation index/M30 apoptotic index)
timeFrame: Baseline and Day 14
measure: Change in steroid sulphatase activity in peripheral blood mononuclear cells (PBMCs).
timeFrame: Baseline and Day 14
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: