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CDK4/6 Inhibitor

Hydroxychloroquine + Abemaciclib for Breast Cancer (ABBY Trial)

Phase 2

Recruiting

Led By Amy Clark, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 cycles (approximately 6 months)

Awards & highlights

ABBY Trial Summary

This trial will study whether using hydroxychloroquine and abemaciclib can reduce the number of disseminated tumor cells in bone marrow.

Who is the study for?

This trial is for adults who've had invasive breast cancer diagnosed within the last 5 years and have finished primary treatments, except endocrine therapy. They must not show signs of cancer recurrence, be able to take oral meds, and meet specific health criteria like good organ function. Pregnant women or those not using birth control are excluded.Check my eligibility

What is being tested?

The study compares hydroxychloroquine (Plaquenil) and abemaciclib (Verzenio), both FDA-approved drugs taken as pills twice daily. It aims to see if these can reduce or eliminate disseminated tumor cells in bone marrow after standard treatment for breast cancer.See study design

What are the potential side effects?

Potential side effects include digestive issues, liver problems, skin reactions from hydroxychloroquine; fatigue, diarrhea, blood count changes from abemaciclib. Side effects vary by individual.

ABBY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 cycles (approximately 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 cycles (approximately 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 cycles (approximately 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Incidence of treatment-emergent adverse events during cycle 1 of the safety cohort (safety of combination HCQ + Abema)

ABBY Trial Design

2Treatment groups

Experimental Treatment

Group I: B (Abema + HCQ)Experimental Treatment2 Interventions

Abemaciclib (100 mg or 150 mg BID*) + Hydroxychloroquine (600 mg BID) *Abemaciclib dose will be determined by safety cohort

Group II: A (Abema)Experimental Treatment1 Intervention

Abemaciclib (150 mg BID)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydroxychloroquine

2017

Completed Phase 4

~5360

Abemaciclib

2019

Completed Phase 2

~1710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,598 Total Patients Enrolled

44 Trials studying Breast Cancer

60,783 Patients Enrolled for Breast Cancer

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

104,998 Total Patients Enrolled

41 Trials studying Breast Cancer

35,267 Patients Enrolled for Breast Cancer

Amy Clark, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine

1 Previous Clinical Trials

18 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04523857 — Phase 2

Breast Cancer Research Study Groups: B (Abema + HCQ), A (Abema)

Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04523857 — Phase 2

Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04523857 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research has been published on Hydroxychloroquine?

"Currently, there are 162 ongoing clinical trials researching the efficacy of hydroxychloroquine. 23 of those active clinical trials are in Phase 3. The majority of studies for hydroxychloroquine are based in Hangzhou, Zhejiang, but there are 5798 locations running studies for this treatment worldwide."

Answered by AI

How many participants are involved in this experiment?

"That is accurate. The information on clinicaltrials.gov shows that this trial is looking for participants right now. This specific trial was originally posted on November 1st 2021 and has had one update since, which was on December 13th 2021. Out of the 1 site, 66 people are needed for the study in total."

Answered by AI

How is Hydroxychloroquine most often used?

"Hydroxychloroquine is most often used as a preventative for malaria. However, it has also shown to be effective in treating conditions like sjögren's syndrome and reducing the risk of recurrence for breast cancer patients."

Answered by AI

Has the Food and Drug Administration cleared hydroxychloroquine for public consumption?

"While Phase 2 trials are not as well supported by data, our team believes that hydroxychloroquine is safe enough to merit a score of 2."

Answered by AI

Are patients being accepted for this treatment program at this time?

"The trial, which is currently looking for 66 individuals at a single site, was first posted on November 1st 2021 and has had one subsequent edit on December 13th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

2021. "ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04523857.

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