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

NCT01230970 | Terminated Phase 2

• 1 other identifier: X-55-58064-005
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Intratumoural levels of sex hormones

  Baseline and Day 14

• Intratumoural steroid sulphatase activity

  Baseline and Day 14

Secondary Outcomes (6)

• Change in the intratumoural Ki67 proliferation index

  Baseline and Day 14

• Proportion of subjects with a decrease in Ki67 staining ≥50%

  Baseline and Day 14

• Proportion of subjects with complete cell cycle response, defined as Ki67 staining ≤1%

  Baseline and Day 14

• Change in Apoptotic Index determined by M30 antibody

  Baseline and Day 14

• Change in Growth Index (Ki67 proliferation index/M30 apoptotic index)

  Baseline and Day 14

Study Arms (1)

BN83495

EXPERIMENTAL

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

Drug: BN83495

Interventions

BN83495 DRUG

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

BN83495

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Akershus University Hospital

Lørenskog, 1474, Norway

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

irosustat

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 29, 2010
• Study Start: May 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

NO (1)