Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022672
Status:
COMPLETED
Last Update Posted:
2013-06-13
First Post:
2001-08-10
Brief Title:
A Study to Evaluate the Efficacy and Safety of Herceptin Trastuzumab in Combination With Arimidex Anastrozole an Aromatase Inhibitor Compared to Arimidex Alone in Patients With Metastatic Breast Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab Herceptin to daily oral anastrozole Arimidex tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 HER2 overexpressing metastatic breast cancer ERve andor PRve Patients were randomized to receive either anastrazole 1 mg per os po daily or anastrazole 1 mg po daily a loading dose of Herceptin 4 mgkg intravenous iv followed by weekly doses of Herceptin 2 mgkg iv The anticipated time on study treatment was until disease progression and the target sample size was 100-500 individuals
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