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

January 4, 2019 updated by: Ipsen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Lørenskog, Norway, 1474
        • Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intratumoural levels of sex hormones
Time Frame: Baseline and Day 14
Baseline and Day 14
Intratumoural steroid sulphatase activity
Time Frame: Baseline and Day 14
Baseline and Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the intratumoural Ki67 proliferation index
Time Frame: Baseline and Day 14
Baseline and Day 14
Proportion of subjects with a decrease in Ki67 staining ≥50%
Time Frame: Baseline and Day 14
Baseline and Day 14
Proportion of subjects with complete cell cycle response, defined as Ki67 staining ≤1%
Time Frame: Baseline and Day 14
Baseline and Day 14
Change in Apoptotic Index determined by M30 antibody
Time Frame: Baseline and Day 14
Baseline and Day 14
Change in Growth Index (Ki67 proliferation index/M30 apoptotic index)
Time Frame: Baseline and Day 14
Baseline and Day 14
Change in steroid sulphatase activity in peripheral blood mononuclear cells (PBMCs).
Time Frame: Baseline and Day 14
Baseline and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X-55-58064-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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