Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04603183
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2020-10-07
Brief Title:
ABemaciclib ET paclItaxel in aGgressive HRHER2- MBC trIaL
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
A Randomized 2-Arm Open-Label Ph-II Study of Abemaciclib Combined With ET w or wo CT With Paclitaxel as 1L in Patients With Unresectable Locally Advanced or Metastatic HRHER2- BC With Aggressive Disease Criteria
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
ABIGAIL
Brief Summary:
This is a multicenter randomized 2 arm open label phase II study It is designed to compare the efficacy and safety of abemaciclib combined with ET letrozole or fulvestrant versus a short course with induction chemotherapy with paclitaxel followed by maintenance therapy with abemaciclib combined with ET letrozole or fulvestrant in patients with previously untreated unresectable locally advanced or metastatic HR positiveHER2 negative breast cancer with aggressive disease criteria
Detailed Description:
The ABIGAIL study aims to provide consistent evidence that the combination of abemaciclib with ET -consisting of letrozole or fulvestrant-as first-line regimen is non-inferior to the optimal first-line chemotherapy -consisting of weekly paclitaxel-in terms of early ORR after the first 12 weeks of treatment in patients with HR-positiveHER2-negative ABC and at least one feature of aggressive disease associated with poor prognosis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001648-24 | EUDRACT_NUMBER | None | None |