Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252811
Status:
WITHDRAWN
Last Update Posted:
2011-01-28
First Post:
2005-11-01
Brief Title:
A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase II Randomised Double-Blind Placebocontrolled Study To Investigate The Effects Of ZD1839 IRESSA On Cell Proliferation In Oestrogen And Progesterone Receptor Negative Breast Cancer Prior To Surgery
Status:
WITHDRAWN
Status Verified Date:
2011-01
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 is a Phase II randomised double-blind placebo-controlled study Subjects with histologically-confirmed oestrogen receptor negative ER- progesterone receptor negative PgR- primary breast cancer breast cancer will be randomly assigned in a 21 ratio to receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks Surgical intervention will take place after 4 weeks on Day 29 and treatment will continue for 1 week after surgery
Detailed Description:
None
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 |
|---|---|---|---|
| D7913C00509 | OTHER | AZ IMPACT | None |