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

Must not have

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.

Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 cycles (approximately 6 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken hydroxychloroquine for more than a month after completing my main cancer treatment.

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I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.

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I have not had major surgery in the last 2 weeks.

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I have been treated with a CDK 4/6 inhibitor before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)