Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01958021
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2013-10-04
Brief Title:
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast CancerMONALEESA-2
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Status:
COMPLETED
Status Verified Date:
2023-04
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:
MONALEESA-2
Brief Summary:
This is a multi-center randomized double-blinded placebo controlled trial
Detailed Description:
The primary purpose of this study was to assess the efficacy of LEE011 as measured by progression free survival PFS in postmenopausal women with HR positive HER2 negative advanced breast cancer who received no prior treatment for advanced disease
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-003084-61 | EUDRACT_NUMBER | None | None |