A Phase II Pilot Trial of ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer Patients ("ABBY")
Abramson Cancer Center at Penn Medicine
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically-confirmed, primary, invasive breast cancer diagnosed within 5 years of entry into the companion DTC screening protocol UPCC 28115 * Qualifying risk status, at diagnosis utilizing receptor testing by ASCO/CAP guidelines, meting at least one of the following: (i) Lymph node involvement a. Pathologically-confirmed positive axillary lymph nodes, regardless of receptors, or (b) Evidence of lymph node involvement by preoperative imaging AND fibrosis and/or treatment effect in lymph nodes after neoadjuvant therapy, regardless of receptor status (ii) Primary…
Interventions
- DrugAbemaciclib
Oral CDK4/6 inhibitor to target bone marrow disseminated tumor cells (DTCs)
- DrugHydroxychloroquine
Oral autophagy inhibitor to target bone marrow disseminated tumor cells (DTCs)
Location
- Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania