OncoMatch/Clinical Trials/NCT04523857
ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer
Is NCT04523857 recruiting? Yes, currently enrolling (May 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
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <10% (<10%)
Primary tumor that is ER/PR/Her2 negative: estrogen receptor (ER) < 10%, progesterone receptor (PR) < 10% and negative for Her2-overexpression by ASCO-CAP guidelines
Required: PR (PGR) expression <10% (<10%)
Primary tumor that is ER/PR/Her2 negative: estrogen receptor (ER) < 10%, progesterone receptor (PR) < 10% and negative for Her2-overexpression by ASCO-CAP guidelines
Required: HER2 (ERBB2) wild-type (negative for Her2-overexpression by ASCO-CAP guidelines)
Primary tumor that is ER/PR/Her2 negative: estrogen receptor (ER) < 10%, progesterone receptor (PR) < 10% and negative for Her2-overexpression by ASCO-CAP guidelines
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: definitive surgery — primary
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 — neoadjuvant
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 — adjuvant
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 — adjuvant
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 — adjuvant
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: CDK4/6 inhibitor
Prior treatment with a CDK 4/6 inhibitor
Cannot have received: hydroxychloroquine
Exception: exposure for a duration of > 1 month since the completion of the patient's primary therapy
Prior hydroxychloroquine exposure for a duration of > 1 month since the completion of the patient's primary therapy (definitive surgery, (neo)adjuvant chemotherapy, adjuvant radiation, and/or Her2-directed therapy) for the index malignancy.
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
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 →
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