- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01230970
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
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
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Lørenskog, Norway, 1474
- Akershus University Hospital
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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.
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40mg tablet oral daily administration from Day 1 to Day 14.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intratumoural levels of sex hormones
Time Frame: Baseline and Day 14
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Baseline and Day 14
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Intratumoural steroid sulphatase activity
Time Frame: Baseline and Day 14
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Baseline and Day 14
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the intratumoural Ki67 proliferation index
Time Frame: Baseline and Day 14
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Baseline and Day 14
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Proportion of subjects with a decrease in Ki67 staining ≥50%
Time Frame: Baseline and Day 14
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Baseline and Day 14
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Proportion of subjects with complete cell cycle response, defined as Ki67 staining ≤1%
Time Frame: Baseline and Day 14
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Baseline and Day 14
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Change in Apoptotic Index determined by M30 antibody
Time Frame: Baseline and Day 14
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Baseline and Day 14
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Change in Growth Index (Ki67 proliferation index/M30 apoptotic index)
Time Frame: Baseline and Day 14
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Baseline and Day 14
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Change in steroid sulphatase activity in peripheral blood mononuclear cells (PBMCs).
Time Frame: Baseline and Day 14
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Baseline and Day 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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