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

Sponsor

Ipsen (Industry)

Overall Status

Terminated

CT.gov ID

NCT01230970

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: BN83495	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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 Start Date :

May 1, 2011

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BN83495 40mg tablet oral daily administration from Day 1 to Day 14.	Drug: BN83495 40mg tablet oral daily administration from Day 1 to Day 14.

Arm

Intervention/Treatment

Experimental: BN83495

40mg tablet oral daily administration from Day 1 to Day 14.

Drug: BN83495

40mg tablet oral daily administration from Day 1 to Day 14.

Outcome Measures

Primary Outcome Measures

Intratumoural levels of sex hormones [Baseline and Day 14]
Intratumoural steroid sulphatase activity [Baseline and Day 14]

Secondary Outcome Measures

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 Growth Index (Ki67 proliferation index/M30 apoptotic index) [Baseline and Day 14]
Change in steroid sulphatase activity in peripheral blood mononuclear cells (PBMCs). [Baseline and Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akershus University Hospital	Lørenskog		Norway	1474

Sponsors and Collaborators

Ipsen

Investigators

Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ipsen

ClinicalTrials.gov Identifier:

NCT01230970

Other Study ID Numbers:

X-55-58064-005

First Posted:

Oct 29, 2010

Last Update Posted:

Jan 7, 2019

Last Verified:

Jan 1, 2019

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jan 7, 2019