Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066378
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2003-08-06
Brief Title:
Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
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 EORTC Randomized Double Blind Placebo-Controlled Phase II Multi-Center Trial Of Anastrozole Arimidex In Combination With ZD 1839 Iressa Or Placebo In Patients With Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-10
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 Estrogen can stimulate the growth of breast cancer cells Hormone therapy using anastrozole may fight breast cancer by reducing the production of estrogen Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Combining anastrozole with gefitinib may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locally recurrent breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locally recurrent breast cancer
Detailed Description:
OBJECTIVES
Compare the 1 year antitumor activity of anastrozole with vs without gefitinib in terms of progression-free survival in postmenopausal women with metastatic or locally recurrent advanced breast cancer
Compare the objective tumor response and duration of tumor response in patients treated with these regimens
Compare the progression-free survival of patients treated with these regimens
Compare the safety of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center dominant site of metastatic disease bone alone vs other prior chemotherapy no vs yes stage metastatic vs locally recurrent and measurability measurable vs evaluable Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral anastrozole and oral gefitinib once daily
Arm II Patients receive oral anastrozole and an oral placebo once daily In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression
PROJECTED ACCRUAL A total of 108 patients 54 per treatment arm will be accrued for this study
Compare the 1 year antitumor activity of anastrozole with vs without gefitinib in terms of progression-free survival in postmenopausal women with metastatic or locally recurrent advanced breast cancer
Compare the objective tumor response and duration of tumor response in patients treated with these regimens
Compare the progression-free survival of patients treated with these regimens
Compare the safety of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center dominant site of metastatic disease bone alone vs other prior chemotherapy no vs yes stage metastatic vs locally recurrent and measurability measurable vs evaluable Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral anastrozole and oral gefitinib once daily
Arm II Patients receive oral anastrozole and an oral placebo once daily In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression
PROJECTED ACCRUAL A total of 108 patients 54 per treatment arm 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 |
|---|---|---|---|
| IDBBC-10021 | None | None | None |
| EORTC-10021 | None | None | None |