Actively Recruiting
ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-05-08
66
Participants Needed
1
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed, primary, invasive breast cancer diagnosed within 5 years
- Qualifying risk status at diagnosis based on receptor testing meeting at least one specified criterion
- Completed all primary therapy at least 4 weeks before study entry with resolved or improving treatment-related toxicity
- Bone marrow aspirate showing detectable disseminated tumor cells after therapy
- No evidence of recurrent breast cancer by physical exam, blood tests, or imaging
- Age 18 years or older
- ECOG performance status 0 to 2
- Ability to swallow oral medications
- No contraindications to study medications or uncontrolled medical illness
- Adequate bone marrow, liver, renal, and muscle function as defined by specific lab values
- Stable anticoagulation allowed under defined conditions
- Ability to provide informed consent
You will not qualify if you...
- Enrollment in another investigational therapy
- Received experimental treatment within 30 days or 5 half-lives before randomization
- Prior treatment with a CDK 4/6 inhibitor
- Known hypersensitivity to hydroxychloroquine or derivatives
- Hydroxychloroquine use for more than 1 month since completing primary therapy
- Use of tamoxifen in hormone-receptor positive breast cancer patients
- Initiation of bone modifying agents within 3 months before study treatment
- Major surgery within 14 days before randomization
- Severe or uncontrolled medical conditions affecting study participation
- Pregnant or breastfeeding women, or adults not using effective birth control
- Women of childbearing potential must have negative pregnancy test within 7 days before first dose
AI-Screening
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Trial Site Locations
Total: 1 location
1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
L
Lauren Bayne, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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