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

NCT04841148 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HCQ

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

DRUG

Avelumab

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

DRUG

Palbociclib

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.

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Angela DeMichele, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2027-07-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841148 on ClinicalTrials.gov