Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322348
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2006-05-03
Brief Title:
Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer ABC Pre-menopausal Women
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
An Open-label Randomised Parallel Group Multicentre Study to Compare ZOLADEX 108 mg Given Every 12 Weeks With ZOLADEX 36 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-12
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:
The primary objective is to evaluate whether Zoladex 108 mg 12-weekly is non-inferior to Zoladex 36 mg 4-weekly in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival at 24 weeks
Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 108 mg and ZOLADEX 36 mg by assessment of adverse events AEsand to assess goserelin PK in Japanese and Caucasian participants who have received ZOLADEX 108 mg by assessment of goserelin plasma concentration time profiles
Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow recruitment 98 vs the planned 260 patients were randomised into the study and will be followed as per protocol for 2 years
Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 108 mg and ZOLADEX 36 mg by assessment of adverse events AEsand to assess goserelin PK in Japanese and Caucasian participants who have received ZOLADEX 108 mg by assessment of goserelin plasma concentration time profiles
Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow recruitment 98 vs the planned 260 patients were randomised into the study and will be followed as per protocol for 2 years
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 |
|---|---|---|---|
| Zoladex ABC Study | None | None | None |