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NCT04523857 · ClinicalTrials.gov registry record · Phase 2
ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT04523857: Recruiting Phase 2 study of Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
NCT04523857 is a Phase 2 study of Breast Cancer that is actively recruiting participants, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 66 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04523857, a Phase 2 study of Breast Cancer, is actively recruiting participants, sponsored by Abramson Cancer Center at Penn Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Rate of protocol defined "severe toxicity" during cycle 1 (4 weeks) of combination HCQ 600mg BID and Abema (at 100 mg and 150 mg BID) in a safety cohort of 6 patients at each dose of Abema
Conditions Studied
Interventions
- DRUG Abemaciclib
- DRUG Hydroxychloroquine
Study Locations (1)
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT04523857 shows while recruiting
NCT04523857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Abemaciclib is the first listed.
NCT04523857 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04523857 about?
NCT04523857 is a clinical study titled "ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer". 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 cell...
What is the current status of trial NCT04523857?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2021-11-01. Estimated completion is 2028-12.
What conditions does trial NCT04523857 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04523857?
The interventions under investigation include: Abemaciclib (DRUG), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT04523857?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04523857 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04523857's enrollment target sits among peer trials
66 718th of 1224 higher than 504 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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