Clinical Trials /

ABemacicliB, HydroxYchloroquine, or the Combination to Target Minimal Residual Disease in Breast Cancer

NCT04523857

Description:

This is a Phase II randomized, controlled, open label breast cancer clinical trial. 66 patients will be enrolled. The drugs being studied are hydroxychloroquine (Plaquenil) and abemaciclib (also Verzenio). This research study is testing whether using these drugs to target the disseminated tumor cells in bone marrow can reduce their number or eliminate them. Both hydroxychloroquine and abemaciclib are pills that will be taken twice daily. Both are approved by the FDA

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: ABemacicliB, HydroxYchloroquine, or the Combination to Target Minimal Residual Disease in Breast Cancer
  • Official Title: A Phase II Pilot Trial of ABemacicliB, HydroxYchloroquine, or the Combination to Target Minimal Residual Disease in Breast Cancer Patients ("ABBY")

Clinical Trial IDs

  • ORG STUDY ID: UPCC 10119
  • NCT ID: NCT04523857

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
AbemaciclibVerzenioA (Abema)
HydroxychloroquinePlaquenilB (Abema + HCQ)

Purpose

This is a Phase II randomized, controlled, open label breast cancer clinical trial. 66 patients will be enrolled. The drugs being studied are hydroxychloroquine (Plaquenil) and abemaciclib (also Verzenio). This research study is testing whether using these drugs to target the disseminated tumor cells in bone marrow can reduce their number or eliminate them. Both hydroxychloroquine and abemaciclib are pills that will be taken twice daily. Both are approved by the FDA

Trial Arms

NameTypeDescriptionInterventions
A (Abema)ExperimentalAbemaciclib (150 mg BID)
  • Abemaciclib
B (Abema + HCQ)ExperimentalAbemaciclib (100 mg or 150 mg BID*) + Hydroxychloroquine (600 mg BID) *Abemaciclib dose will be determined by safety cohort
  • Abemaciclib
  • Hydroxychloroquine

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically-confirmed, primary, invasive breast cancer diagnosed within 5 years of
             entry into a companion DTC screening protocol.

          -  Qualifying risk status, at diagnosis utilizing receptor testing by ASCO/CAP guidelines

          -  Patients must have completed all primary 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 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 after completion of therapy demonstrates detectable DTCs (via
             IHC)

          -  No evidence of recurrent local or distant breast cancer by physical examination, blood
             tests or symptom-directed imaging, per NCCN guidelines.

          -  ECOG performance status =/< 2

          -  Ability to swallow oral medications

          -  No contraindications to the study medications or uncontrolled medical illness.

          -  Adequate bone marrow function

          -  Adequate liver function

          -  Adequate renal function

          -  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

          -  Prior treatment with a CDK 4/6 inhibitor

          -  Known hypersensitivity to hydroxychloroquine or any of its derivatives

          -  Patients with hormone-receptor positive breast cancer may not be receiving tamoxifen
             due to drug-drug interactions with hydroxychloroquine

          -  Patients who have received bone modifying agents within 3 months

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of treatment-emergent adverse events during cycle 1 of the safety cohort (safety of combination HCQ + Abema)
Time Frame:Toxicity is assessed over the first cycle (4 weeks) of treatment
Safety Issue:
Description: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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

Last Updated

August 19, 2020