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RECRUITING
NCT04841148
PHASE2

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

Sponsor: Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2021-06-01

Completion Date

2028-05

Last Updated

2026-04-09

Healthy Volunteers

No

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.

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