Ignite Creation Date:
2024-05-05 @ 11:53 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01446159
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2011-09-12
Brief Title:
Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase 1b2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor AI Versus AI Alone in Women With Metastatic Breast Cancer MBC
Status:
COMPLETED
Status Verified Date:
2020-05
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:
Study to evaluate the safety tolerability antitumor activity and pharmacology of MEDI-573 in combination with an aromatase inhibitor AI in adult subjects with HR HER2-negative MBC
Detailed Description:
This is a Phase 1b2 multicenter open-label study to evaluate the safety tolerability antitumor activity and pharmacology of MEDI-573 in combination with an AI in adult subjects with HR HER2-negative MBC This study has 2 phases a dose-evaluation phase Phase 1b and a randomization phase Phase 2
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