Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03176238
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2017-06-01
Brief Title:
Study in Post-menopausal Women With Hormone Receptor Positive HER2-negative Advanced Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IIIb Multi-center Open-label Study of RAD001 in Combination With EXemestane in Post-menopausal Women With EStrogen Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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:
EVEREXES
Brief Summary:
This international multi-center open-label single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors NSAI therapy in Novartis Oncology emergent growth market EGM countriesData was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy Summary statistics were presented
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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