Ph II Early BC Pre-Surgical Biologic Study | NCT00637026

Studies
Ph II Early BC Pre-Surgical Biologic Study

NCT00637026

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Apr 23, 2009Estimated

Enrollment

65Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Gefitinib

Countries

Not provided

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

Apr 2009

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

Jul 2003

Primary Completion Date

Not provided

Completion Date

Feb 2005Actual

First Submitted Date

Mar 10, 2008

First Submission Date that Met QC Criteria

Mar 14, 2008

First Posted Date

Mar 17, 2008Estimated

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

Apr 22, 2009

Last Update Posted Date

Apr 23, 2009Estimated

Name	Class
Cancer International Research Group (CIRG)	OTHER

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

A pre-surgery study to assess changes that occur in human breast cancer material and normal skin after a short course of treatment with Iressa.

Detailed Description

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

65Estimated

Name	Type	Description	Arm Group Labels	Other Names
Gefitinib	Drug	Iressa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Molecular alterations occuring in breast cancer tissue following Iressa treatment		At time of diagnosis and time of patient surgery

Secondary Outcomes

Measure	Description	Time Frame
Molecular alterations occurring in normal skin tissue following Iressa treatment		At time of diagnosis and time of patient surgery
To correlate molecular changes with pharmacokinetic parameters		At time of diagnosis and time of patient surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Invasive breast cancer, Aged 18 years or older, Not more than 28 days from initial diagnosis

Exclusion Criteria:

Pregnant or lactating patients, Prior or current radiotherapy for breast cancer, Known allergy reaction to Iressa

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077156	Gefitinib

Ancestor Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided