Ignite Creation Date:
2024-05-06 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03671330
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2018-09-12
Brief Title:
Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive HER2-negative Advanced Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Phase II Randomized Double-blind Placebo-controlled Study of LEE011Ribociclib or Placebo in Combination With Endocrine Therapy for the Treatment of Pre- and Postmenopausal Chinese Women With HR Positive HER2-negative Advanced Breast Cancer Including a Subset With Pharmacokinetic Analysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 is a Phase II randomized double-blind placebo-controlled study involving premenopausal and postmenopausal Chinese women plus an open-label single arm of pharmacokinetic cohort of LEE011 in combination with Letrozole in Chinese postmenopausal women with HR HER2- negative advanced breast cancer
Three cohorts of patients will be enrolled PK cohort premenopausal cohort and postmenopausal cohort
Three cohorts of patients will be enrolled PK cohort premenopausal cohort and postmenopausal cohort
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