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

• Status: Recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Hydroxychloroquine

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