Study on Avelumab or Hydroxychloroquine, With or Without Palbociclib, to Eliminate Dormant Breast Cancer
Sponsor: Abramson Cancer Center at Penn Medicine
ClinicalTrials ID:NCT04841148
This clinical trial is exploring whether using Avelumab or Hydroxychloroquine, with or without Palbociclib, can safely and effectively target dormant breast cancer cells in the bone marrow of patients with early-stage ER+ breast cancer after surgery and standard treatment.
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Program Overview
The aim of this study is to find out if Avelumab or Hydroxychloroquine, with or without Palbociclib, can help prevent breast cancer from coming back by targeting dormant cancer cells in the bone marrow. These cells can sometimes lead to cancer returning in a more serious form. The study will look at how these drugs work together to stop these cells from staying dormant and potentially causing cancer to return.
Description
This trial is focused on preventing the return of breast cancer by targeting dormant cancer cells in the bone marrow that remain after initial treatment. These cells can sometimes lead to incurable metastatic breast cancer. The study will test different combinations of drugs: Avelumab, which blocks a pathway that helps cancer cells hide from the immune system; Hydroxychloroquine, which stops a process called autophagy that helps cancer cells survive; and Palbociclib, which blocks a pathway that helps cancer cells grow. The trial will explore how these drugs can work together to eliminate dormant cancer cells and reduce the risk of cancer returning. Researchers will also study the relationship between the primary tumor and these dormant cells, as well as the role of various biomarkers in identifying patients with minimal residual disease and measuring the response of dormant cells to treatment.
Eligibility Criteria
Inclusion Criteria
- Have detectable dormant tumor cells in the bone marrow after completing all main treatments for breast cancer.
- Have a history of stage II-III ER+/Her2 negative invasive breast cancer with no signs of cancer returning.
- Have completed all primary and adjuvant therapy, except for ongoing endocrine therapy.
- May have received previous CDK4/6 inhibitor therapy, but not Palbociclib, and must have stopped it at least 6 months before screening.
- Must be on adjuvant endocrine therapy at the time of enrollment, with specific guidelines for those on tamoxifen.
- Can continue bone-modifying agents if already receiving them at screening.
- Must not be enrolled in another investigational therapy trial.
- Must be 18 years or older.
- Must not have any contraindications to the study medications or uncontrolled medical illnesses.
- Must have adequate bone marrow, liver, and kidney function.
- Must be able to speak and understand English.
Exclusion Criteria
- Have a history of another invasive breast cancer or certain other cancers unless disease-free for at least 5 years.
- Are on chronic, high-dose systemic corticosteroids or other immunosuppressive agents.
- Have a heart condition with a prolonged QT interval on an EKG.
- Have severe or uncontrolled medical conditions, including certain autoimmune diseases, heart conditions, lung diseases, uncontrolled diabetes, severe infections, or liver disease.
- Are HIV positive and on combination anti-retroviral therapy.
- Have gastrointestinal issues that affect the absorption of Hydroxychloroquine.
- Have an active bleeding disorder or are on therapeutic anticoagulation.
- Have a history of eye conditions like retinopathy.
- Are pregnant, breastfeeding, or not using effective birth control if of reproductive potential.
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