Trials / Recruiting
RecruitingNCT04523857
ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer
A Phase II Pilot Trial of ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer Patients ("ABBY")
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abemaciclib | Oral CDK4/6 inhibitor to target bone marrow disseminated tumor cells (DTCs) |
| DRUG | Hydroxychloroquine | Oral autophagy inhibitor to target bone marrow disseminated tumor cells (DTCs) |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2027-12-01
- Completion
- 2028-12-01
- First posted
- 2020-08-24
- Last updated
- 2025-04-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04523857. Inclusion in this directory is not an endorsement.