Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066339
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2003-08-06
Brief Title:
Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
An IDBBC Single Arm Phase II Trial Evaluating The Activity Of Iressa ZD1839 In Metastatic Breast Cancer Patients Pretreated With An Antiestrogen And A Non-Steroidal Aromatase Inhibitor Anastrozole Or Letrozole
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
PURPOSE Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy
PURPOSE Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy
Detailed Description:
OBJECTIVES
Determine the clinical benefit rate defined as complete response partial response or stable disease after at least 24 weeks in patients receiving gefitinib for metastatic breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase inhibitor therapy
Determine the best overall response rate of patients treated with this drug
Determine the progression-free survival of patients treated with this drug
Determine the duration of response in patients treated with this drug
Determine the safety of this drug in these patients
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive oral gefitinib once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients who go off study in the absence of disease progression are followed every 8 weeks until disease progression
PROJECTED ACCRUAL A total of 44 patients will be accrued for this study
Determine the clinical benefit rate defined as complete response partial response or stable disease after at least 24 weeks in patients receiving gefitinib for metastatic breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase inhibitor therapy
Determine the best overall response rate of patients treated with this drug
Determine the progression-free survival of patients treated with this drug
Determine the duration of response in patients treated with this drug
Determine the safety of this drug in these patients
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive oral gefitinib once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Patients who go off study in the absence of disease progression are followed every 8 weeks until disease progression
PROJECTED ACCRUAL A total of 44 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-10012 | None | None | None |
| IDBBC-10012 | None | None | None |