Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-30 @ 2:26 PM
Study NCT ID:
NCT02107703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-21
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03763604
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
MONARCH 2
Brief Summary:
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant.
For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.
For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: