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
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Incidence of treatment-emergent adverse events during cycle 1 of the safety cohort (safety of combination HCQ + Abema)
Timeframe: Toxicity is assessed over the first cycle (4 weeks) of treatment
Change in bone marrow DTC number evaluated by DTC-IHC assay after 6 cycles of therapy compared to baseline (Efficacy of Abema +/- HCQ in eliminating bone marrow DTCs)
Timeframe: 6 cycles (approximately 6 months)
Lauren Bayne, PhD