Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077025
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2004-02-09
Brief Title:
Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor andor Progesterone Receptor Metastatic Breast Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Phase II Multicenter Double-Blind Randomized Trial Comparing Anastrozole ZD1033 Arimidex-Placebo to the Combination Anastrozole-ZD1839 Gefitinib IRESSA in Postmenopausal Patients With Estrogen Receptor ER andor Progesterone Receptor PgR Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-07
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:
This study is being carried out to see if treatment with ZD1839 Gefitinib combined with Arimidex Anastrozole has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer
Detailed Description:
This is a phase II multicenter double-blind randomized placebo-controlled trial Patients will be randomized in a double-blind manner in a 11 ratio to receive either 250 mgday ZD1839 or matched placebo in combination with 1 mgday anastrozole The dose of ZD1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mgday The 1 mg dose of anastrozole is the standard approved dose
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