drugset / Trial / NCT04523857

ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

NCT04523857

Phase 2 Recruiting 44 enrolled Abramson Cancer Center at Penn Medicine
RandomizedSequentialOpen-labelTreatment

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

Timeline

Start
2021-11-01
Primary completion
2027-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule 100 mg Oral
Subject Abemaciclib Small molecule 150 mg Oral
Subject Hydroxychloroquine Small molecule 600 mg Oral

Indications