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
Phase 2
55 Years
80 Years
55 Years
80 Years
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Intratumoural levels of sex hormones
Outcome Time Frame:
Baseline and Day 14
Safety Issue:
No
Principal Investigator
Anne Kornowski, MD
Investigator Role:
Study Director
Investigator Affiliation:
Ipsen
Authority:
Norway: Norwegian Medicines Agency
Study ID:
X-55-58064-005
NCT ID:
NCT01230970
Start Date:
May 2011
Completion Date:
May 2011
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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