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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01230970
• Other study ID #: X-55-58064-005
• Status: Terminated
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: May 2011

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• BN83495
40mg tablet oral daily administration from Day 1 to Day 14.

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intratumoural levels of sex hormones		Baseline and Day 14
Primary	Intratumoural steroid sulphatase activity		Baseline and Day 14
Secondary	Change in the intratumoural Ki67 proliferation index		Baseline and Day 14
Secondary	Proportion of subjects with a decrease in Ki67 staining =50%		Baseline and Day 14
Secondary	Proportion of subjects with complete cell cycle response, defined as Ki67 staining =1%		Baseline and Day 14
Secondary	Change in Apoptotic Index determined by M30 antibody		Baseline and Day 14
Secondary	Change in Growth Index (Ki67 proliferation index/M30 apoptotic index)		Baseline and Day 14
Secondary	Change in steroid sulphatase activity in peripheral blood mononuclear cells (PBMCs).		Baseline and Day 14