RecruitingPhase 2NCT04841148

Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer

A Phase II Trial of Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer (PALAVY)


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

96 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial will assess the safety and early efficacy of Hydroxychloroquine or Avelumab, with or without Palbociclib, in early-stage ER+ breast cancer patients who are found to harbor disseminated tumor cells (DTCs) in the bone marrow after definitive surgery and standard adjuvant therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether low doses of the drug avelumab (an immunotherapy), hydroxychloroquine (a drug that may prevent dormant cancer cells from hiding), or palbociclib (a targeted therapy) can eliminate remaining hidden breast cancer cells in the bone marrow in women with hormone-receptor-positive, HER2-negative breast cancer who have no obvious signs of recurrence. **You may be eligible if:** - You have stage II or III hormone receptor-positive, HER2-negative breast cancer - You have finished all primary treatment (surgery, chemotherapy, radiation) except ongoing hormone therapy - A bone marrow test found detectable tumor cells - You are currently on adjuvant hormone therapy and enrolled within 2–7 years of starting it - You are 18 or older **You may NOT be eligible if:** - You have a history of another invasive breast cancer - You have uncontrolled diabetes, active autoimmune disease, severe heart or lung disease, or liver cirrhosis - You have an abnormal heart rhythm (QTc over 480 ms) - You are pregnant or breastfeeding - You are on high-dose steroids or immunosuppressants Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHCQ

600 mg tablets twice daily D1-28 of each 28-day cycle

DRUGAvelumab

10 mg/kg, IV, D1 and D15 of each 28-day cycle

DRUGPalbociclib

125 mg capsule daily, by mouth on D1-21 concurrently with Avelumab. Or 75 mg capsule daily, by mouth on D1-28 concurrently with HCQ.


Locations(7)

Georgetown University

Washington D.C., District of Columbia, United States

University of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Washington

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04841148


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