Evaluation of Antiproliferative Effects of Arimidex in Du... | NCT01207635

Studies
Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer

NCT01207635

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Jul 30, 2012Estimated

Enrollment

42Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Ductal Lavage Fluid Collection

Countries

United States

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

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

Jan 2006Actual

Completion Date

Jan 2006Actual

First Submitted Date

Sep 21, 2010

First Submission Date that Met QC Criteria

Sep 22, 2010

First Posted Date

Sep 23, 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

Jul 27, 2012

Last Update Posted Date

Jul 30, 2012Estimated

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

Description Module

Brief Summary

The goal of this study is to evaluate antiproliferative effects of Arimidex in ductal lavage fluids of Breast Cancer patients.

Breast cancer is the leading cause of cancer incidence and the second leading cause of cancer mortality in women. Breast duct fluid provide biomarkers to aid in risk assessment of developing breast cancer.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breast Cancer Patients			Procedure: Ductal Lavage Fluid Collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ductal Lavage Fluid Collection	Procedure	Procedure of inserting a small catheter into the ductal openings in the nipple and washing out cells from inside the duct.	Breast Cancer Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients with Antiproliferative Effects of Arimidex	Biomarker modulation study on effects of Armimidex in ductal lavage fluid from evaluable epithelial cells specimen.	Study duration 4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient must have a history of breast cancer.
Patient must be scheduled to receive standard treatment with Arimidex for adjuvant hormonal management.
Patient must be willing to undergo a duct lavage.
Patient must sign an Informed Consent.

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Breast cancer patients receiving standard Arimidex treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Banu Arun, MD	UT MD Anderson Cancer Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT MD Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
UT MD Anderson Cancer Center website	View source

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided