Actively Recruiting
Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-04-09
96
Participants Needed
7
Research Sites
360 weeks
Total Duration
On this page
Sponsors
A
Abramson Cancer Center at Penn Medicine
Lead Sponsor
J
Johns Hopkins University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bone marrow aspirate after all definitive therapy shows detectable disseminated tumor cells
- History of stage II-III ER+/HER2-negative invasive breast cancer with no recurrence
- ER+/HER2-negative status confirmed on primary tumor
- Completed all primary and adjuvant therapy except adjuvant endocrine therapy
- Prior CDK4/6 inhibitor therapy allowed if stopped at least 6 months before screening
- Receiving adjuvant endocrine therapy at enrollment within 2-7 years of start
- Tamoxifen use not allowed during treatment in hydroxychloroquine arms unless switched to aromatase inhibitor 21 days prior
- Premenopausal patients on ovarian suppression eligible
- Bone modifying agents allowed if started before screening but not initiated during study
- No concurrent enrollment on other investigational therapy trials
- Men and women age 18 years or older
- No contraindications to study medications or uncontrolled medical illness
- Adequate bone marrow, liver, and renal function
- Ability to speak and understand English
You will not qualify if you...
- History of another prior invasive breast cancer (except DCIS diagnosed more than 5 years ago)
- Chronic high-dose systemic corticosteroid or other immunosuppressive agent use
- QTc interval over 480 ms on EKG
- Severe or uncontrolled medical conditions affecting study participation including chronic autoimmune disease, significant cardiovascular risk, pneumonitis or severe lung impairment, uncontrolled diabetes, infections, liver disease
- HIV positive patients on combination anti-retroviral therapy
- Gastrointestinal conditions affecting hydroxychloroquine absorption
- Active bleeding disorders or therapeutic anticoagulation
- History of retinopathy or retinal vein occlusion
- Pregnant or breastfeeding females or adults of reproductive potential not using effective birth control methods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
3
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
7
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
L
Lauren Bayne, PhD
CONTACT
P
Pauleen Sanchez, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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