OncoMatch/Clinical Trials/NCT04523857
ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer
Is NCT04523857 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Abemaciclib and Hydroxychloroquine for breast cancer.
Treatment: Abemaciclib · Hydroxychloroquine — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: CDH1 expression (detectable DTCs (via IHC))
Bone marrow aspirate ... demonstrates detectable DTCs (via IHC)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: definitive surgery — index malignancy
Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry.
Must have received: neoadjuvant chemotherapy — index malignancy
Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry.
Must have received: adjuvant chemotherapy — index malignancy
Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry.
Must have received: adjuvant radiation — index malignancy
Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry.
Must have received: HER2-targeted therapy — index malignancy
Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry.
Cannot have received: abemaciclib (abemaciclib)
Prior treatment with abemaciclib is not allowed.
Cannot have received: hydroxychloroquine (hydroxychloroquine)
Exception: duration > 1 month since completion of primary therapy
Prior hydroxychloroquine exposure for a duration of > 1 month since the completion of the patient's primary therapy
Lab requirements
Blood counts
ANC >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, Hb >9 g/dL
Kidney function
serum creatinine <= 1.5 x ULN
Liver function
Serum bilirubin <= 1.5 x ULN, ALT and AST <= 3.0 x ULN, and INR <=1.5
Adequate bone marrow function as shown by: ANC >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, Hb >9 g/dL; Adequate liver function as shown by: Serum bilirubin <= 1.5 x ULN, ALT and AST <= 3.0 x ULN, and INR <=1.5; Adequate renal function: serum creatinine <= 1.5 x ULN; Adequate muscle function: creatinine phosphokinase (CPK) <= 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Abramson Cancer Center of the University of Pennsylvania · Philadelphia, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04523857 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior abemaciclib, hydroxychloroquine disqualifies patients from enrollment.
Does this trial require CDH1?
Yes, CDH1 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages