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RECRUITING
NCT04523857
PHASE2

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

Sponsor: Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

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

Official title: A Phase II Pilot Trial of ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer Patients ("ABBY")

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2021-11-01

Completion Date

2028-12

Last Updated

2025-04-04

Healthy Volunteers

No

Conditions

Interventions

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)

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States