RecruitingPhase 2NCT04523857

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")


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

44 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether abemaciclib (a targeted cancer drug that blocks cell division) with or without hydroxychloroquine can eliminate residual cancer cells that may persist in the bone marrow after initial breast cancer treatment — potentially preventing recurrence. **You may be eligible if...** - You have been diagnosed with invasive breast cancer within the past 5 years - Your cancer had high-risk features such as positive lymph nodes, large tumor size, HER2-positive status, or triple-negative status - Sensitive bone marrow testing has detected small numbers of remaining cancer cells (disseminated tumor cells) **You may NOT be eligible if...** - Your breast cancer has already spread to distant organs (stage IV) - You have significant heart rhythm problems (QT prolongation) - You have retinal eye disease that would be worsened by hydroxychloroquine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)


Locations(1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT04523857


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