Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-28 @ 10:17 AM
Study NCT ID:
NCT04523857
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Study Overview
Official Title:
A Phase II Pilot Trial of ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer Patients ("ABBY")
Status:
RECRUITING
Status Verified Date:
2025-04
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:
ABBY
Brief Summary:
This is a Phase II randomized, controlled, open label breast cancer clinical trial. 66 patients will be enrolled. The drugs being studied are hydroxychloroquine (Plaquenil) and abemaciclib (also Verzenio). This research study is testing whether using these drugs to target the disseminated tumor cells in bone marrow can reduce their number or eliminate them. Both hydroxychloroquine and abemaciclib are pills that will be taken twice daily. Both are approved by the FDA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: