Study on Abemaciclib and Hydroxychloroquine for Targeting Minimal Residual Disease in Breast Cancer

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04523857

Provider View

This clinical trial is testing whether the combination of two drugs, abemaciclib and hydroxychloroquine, can reduce or eliminate remaining cancer cells in the bone marrow of breast cancer patients. Both drugs are taken as pills twice a day and are approved by the FDA.

Patient Parameters

Program Overview

This Phase II clinical trial involves 66 breast cancer patients and aims to find out if the drugs abemaciclib (Verzenio) and hydroxychloroquine (Plaquenil) can target and reduce the number of cancer cells left in the bone marrow after initial treatment. Participants will take these medications orally twice daily.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary invasive breast cancer within the last 5 years.
  • Must meet certain risk criteria based on tumor characteristics and previous treatments.
  • Completed all primary cancer treatments at least 4 weeks before joining the study.
  • No signs of cancer recurrence based on physical exams, blood tests, and imaging.
  • Age 18 or older.
  • Able to swallow pills.
  • No medical conditions that would prevent taking the study medications.
  • Adequate blood, liver, and kidney function based on specific lab tests.
  • Able to provide informed consent.

Exclusion Criteria

  • Currently participating in another clinical trial or investigational therapy.
  • Received experimental treatment in the last 30 days.
  • Previous treatment with a CDK 4/6 inhibitor.
  • Allergic to hydroxychloroquine or similar drugs.
  • Taking tamoxifen for hormone-receptor positive breast cancer.
  • Started bone modifying agents within 3 months before the study.
  • Had major surgery within 14 days before starting the study.
  • Severe or uncontrolled medical conditions.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.

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