Exploratory Study to Assess the Short Term Intratumoural... | NCT01230970

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

NCT01230970

Sponsor

Ipsen

Status

Terminated

Last Update Posted

Jan 7, 2019Actual

Enrollment

2Actual

Phase

Phase 2

Conditions

Breast Cancer

Interventions

BN83495

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.

Expanded Access Info

Start Date

May 2011

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Oct 20, 2010

First Submission Date that Met QC Criteria

Oct 28, 2010

First Posted Date

Oct 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2019

Last Update Posted Date

Jan 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BN83495	Experimental	40mg tablet oral daily administration from Day 1 to Day 14.	Drug: BN83495

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BN83495	Drug	40mg tablet oral daily administration from Day 1 to Day 14.	BN83495

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intratumoural levels of sex hormones		Baseline and Day 14
Intratumoural steroid sulphatase activity		Baseline and Day 14

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases