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

NCT ID: NCT01230970

Last Updated: 2019-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-05-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

BN83495

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

Group Type: EXPERIMENTAL

BN83495

Intervention Type: DRUG

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

Interventions

BN83495

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Akershus University Hospital

Lørenskog, , Norway

Countries

Norway

Other Identifiers

X-55-58064-005

Identifier Type: -

Identifier Source: org_study_id