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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: BN83495

• Registration Number: NCT01230970
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-10-29
• Study Start: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BN83495	BN83495	40mg tablet oral daily administration from Day 1 to Day 14.

Primary Outcome Measures

Name	Time	Method
Intratumoural levels of sex hormones	Baseline and Day 14
Intratumoural steroid sulphatase activity	Baseline and Day 14

Secondary Outcome Measures

Name	Time	Method
Change in the intratumoural Ki67 proliferation index	Baseline and Day 14
Proportion of subjects with a decrease in Ki67 staining ≥50%	Baseline and Day 14
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 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

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway