Abemaciclib and Hydroxychloroquine for Breast Cancer
This study is for people with breast cancer diagnosed within the last 5 years. It's testing if two approved medications, abemaciclib (Verzenio) and hydroxychloroquine (Plaquenil), can reduce or eliminate breast cancer cells that have spread to the bone marrow. You would take these pills twice daily. Researchers will look at how safe the combination of these drugs is during the first month. They will also measure the number of cancer cells in your bone marrow after about six months to see if the treatments are effective. To join, you must have primary, invasive breast cancer and meet certain risk criteria, such as having lymph node involvement.
- Study design
- This is a Phase II, randomized, controlled, open-label study planning to enroll 66 participants.
- What's involved
- You would take abemaciclib and hydroxychloroquine pills twice daily. Safety will be assessed over the first four weeks, and efficacy will be evaluated after approximately six months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary efficacy endpoint is measured after 6 cycles (approximately 6 months) of therapy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04523857
ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentAbramson Cancer Center at Penn MedicineInvestigator-initiated
~44 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:AbemaciclibHydroxychloroquine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events during cycle 1 of the safety cohort (safety of combination HCQ + Abema)
Measured over Toxicity is assessed over the first cycle (4 weeks) of treatment
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Amy Clark, MD · PRINCIPAL_INVESTIGATOR · Abramson Cancer Center at Penn Medicine
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically-confirmed, primary, invasive breast cancer diagnosed within 5 years of entry into the companion DTC screening protocol UPCC 28115
Qualifying risk status, at diagnosis utilizing receptor testing by ASCO/CAP guidelines, meting at least one of the following:
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. Prior treatment-related toxicity must be resolved or improving to Grade 1 with the exception of alopecia, Grade 2 endocrine disorders (e.g. adrenal insufficiency or thyroid disorders from prior immunotherapy) controlled on stable replacement therapy for \> 1 year, and up to Grade 3 peripheral neuropathy, prior to study enrollment. Concurrent receipt of adjuvant endocrine and bone modifying agents is allowed per standard of care guidelines. Tamoxifen is not allowed due to drug-drug interactions with HCQ.
Bone marrow aspirate obtained via research trial UPCC 28115 after completion of therapy (except endocrine therapy) demonstrates detectable DTCs (via IHC)
No evidence of recurrent local or distant breast cancer by physical examination, blood tests (CBC, LFTs, Alk Phos), or imaging. Assessment for overt metastatic disease by radiologic testing per institutional guidelines (CT Chest, Abdomen and Pelvis, bone scan, MRI and/or PET/CT) will only be done in patients with DTCs detected on bone marrow aspirate who are being screened for this trial.
Age \>/= 18 years
ECOG performance status =/\< 2
Ability to swallow oral medications
No contraindications to the study medications or uncontrolled medical illness.
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
Anticoagulation is allowed if target INR =/\< 1.5 on a stable dose of warfarin or on a stable dose of anticoagulant for \>2 weeks at time of randomization
Ability to provide informed consent
Exclusion
Concurrent enrollment on another investigational therapy
Patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization (or treatment assignment), or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.
Prior treatment with abemaciclib is not allowed. (Patients may have received prior CDK4/6 inhibitor therapy with an agent other than abemaciclib. Patients must have discontinued CDK4/6 inhibitor at least 6 months prior to screening.)
Known hypersensitivity to hydroxychloroquine or any of its derivatives
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.
Patients with hormone-receptor positive breast cancer may not be receiving tamoxifen due to drug-drug interactions with hydroxychloroquine
Patients who have initiated bone modifying agents within 3 months prior to the start of study treatment
Patients who have had major surgery within 14 days prior to randomization (or treatment assignment)
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of Abema
What this trial measures
- Incidence of treatment-emergent adverse events during cycle 1 of the safety cohort (safety of combination HCQ + Abema)Toxicity is assessed over the first cycle (4 weeks) of treatment
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
- Change in bone marrow DTC number evaluated by DTC-IHC assay after 6 cycles of therapy compared to baseline (Efficacy of Abema +/- HCQ in eliminating bone marrow DTCs)6 cycles (approximately 6 months)
Frequency of "clearance" of bone marrow DTCs by arm after 6 cycles of study treatment.