Can a malaria drug help wipe out breast Cancer's hidden seeds?
NCT ID NCT04523857
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether two oral drugs, abemaciclib (a targeted cancer therapy) and hydroxychloroquine (an older malaria drug), can eliminate leftover cancer cells hiding in the bone marrow of breast cancer patients. About 44 people with a history of breast cancer and detectable residual cells will take one or both pills twice daily for six cycles. The goal is to see if the combination is safe and can clear these cells, which may lower the chance of the cancer returning.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- abemaciclib (Verzenio) and hydroxychloroquine (Plaquenil)
- What this could lead to
- If successful, this could show a way to clear leftover cancer cells in the bone marrow, potentially reducing the risk of breast cancer recurrence.
- What could go wrong
- This is a small, early-phase trial with only 44 participants, so results may not apply broadly. The combination of drugs may cause side effects, and it's not yet known if clearing these cells will actually prevent cancer from coming back.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: (i) Lymph node involvement a. Pathologically-confirmed positive axillary lymph nodes, regardless of receptors, or (b) Evidence of lymph node involvement by preoperative imaging AND fibrosis and/or treatment effect in lymph nodes after neoadjuvant therapy, regardless of receptor status (ii) 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, regardless of lymph nodes status (iii) Primary tumor that is ER+/Her2 negative/Lymph node negative with Breast Cancer Recurrence Score of \>/= 25 per the Genomic Health Oncotype DX breast cancer test and/or high risk MammaPrint (iv) Evidence of residual disease in the breast on pathologic assessment after neoadjuvant chemotherapy * 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 Criteria * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Abramson Cancer Center of the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
Contact Email: •••••@•••••
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