Phase II Trial of Preoperative Therapy With Gefitinib and... | NCT00239343

Studies
Phase II Trial of Preoperative Therapy With Gefitinib and Chemotherapy in Patients With ERneg Breast Cancer

NCT00239343

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 27, 2011Estimated

Enrollment

160Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

gefitinib

Countries

Denmark
Norway
Sweden

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 2011

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

Oct 2004

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Oct 14, 2005

First Submission Date that Met QC Criteria

Oct 14, 2005

First Posted Date

Oct 17, 2005Estimated

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 25, 2011

Last Update Posted Date

Jan 27, 2011Estimated

Description Module

Brief Summary

The aim of the study is to estimate the effect of preoperative gefitinib on the complete pathological response rate in primary estrogen receptor negative breast cancer at the time of surgery.

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

160Estimated

Name	Type	Description	Arm Group Labels	Other Names
gefitinib	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the complete pathological response rate in the two study groups at trial closure

Secondary Outcomes

Measure	Description	Time Frame
complete and overall objective tumuor response at trial closure according to the RECIST criteria in the per-protocol population

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically confirmed oestrogen receptor negative primary breast cancer, tumour stage T2-3, N0-2, M0. Eligible for surgery, WHO performance score 0-1.

Exclusion Criteria:

any prior anticancer therapy including gefitinib (Iressa®), epirubicin (Farmorubicin™), or cyclophosphamide, distant metastases or bilateral breast cancer, any evidence of clinically active interstitial lung disease , other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ, pregnancy or breastfeeding

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AstraZeneca Oncology Medical Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Århus C			Denmark
Research Stie

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