Status:
TERMINATED
Exploratory Study to Assess the Short Term Intratumoural and Peripheral Effects of BN83495 in Postmenopausal Women With Newly Diagnosed Breast Cancer
Lead Sponsor:
Ipsen
Conditions:
Breast Cancer
Eligibility:
FEMALE
55-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01230970
Start Date
May 1 2011
End Date
May 1 2011
Last Update
January 7 2019
Active Locations (1)
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1
Akershus University Hospital
Lørenskog, Norway, 1474