Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300781
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2006-03-07
Brief Title:
Study Evaluating HKI-272 Neratinib In Subjects With Advanced Breast Cancer
Sponsor:
Puma Biotechnology Inc
Organization:
Puma Biotechnology Inc
Study Overview
Official Title:
Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-08
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 purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 HER2 positive breast cancer
Detailed Description:
Arm A HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin Arm B HER2 gene amplification and no prior Herceptin or HER2-targeted treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None