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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT04841148
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HCQ — DRUG
    600 mg tablets twice daily D1-28 of each 28-day cycle
  • Avelumab — DRUG
    10 mg/kg, IV, D1 and D15 of each 28-day cycle
  • Palbociclib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HCQ
    Patients will receive HCQ, 600 mg twice daily D1-28 of each 28-day cycle.
  • Experimental: Avelumab
    Patients will receive Avelumab, 10 mg/kg, IV, D1 and D15 of each 28-day cycle.
  • Experimental: Palbociclib and Avelumab
    Patients will receive Palbociclib 125 mg daily, by mouth on D1-21 concurrently with Avelumab, 10 mg/kg IV on D1 and D15 of each 28-day cycle
  • Experimental: Palbociclib and HCQ
    Patients will receive Palbociclib 75 mg daily, by mouth on D1-28 concurrently with HCQ, 600 mg twice daily D1-28 of each 28-day cycle.

Primary Outcome Measure

Determine the efficacy of HCQ or Avelumab, alone or in combination with Palbociclib, in eradicating DTCs [ Time Frame: Efficacy is assessed at the end of Cycle 6 (each cycle is 28 days). ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Georgetown UniversityWashington D.C.District of Columbia20007
Claudine Isaacs, MD
[email protected]
University of ChicagoChicagoIllinois60637
Nan Chen, MD
[email protected]
Indiana UniversityIndianapolisIndiana46202
Kathy Miller, MD
[email protected]
Dana-Farber Cancer InstituteBostonMassachusetts02215
Erica Mayer, MD, MPH
[email protected]
University of PennsylvaniaPhiladelphiaPennsylvania19104
Lauren Bayne, PhD
[email protected]
215-615-2367
Vanderbilt UniversityNashvilleTennessee37232
Sonya Reid, MD
[email protected]
University of WashingtonSeattleWashington98195
Rachel Yung, MD
[email protected]

Find similar trials in Washington D.C., DC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Georgetown University· Washington D.C., DCUniversity of Chicago· Chicago, ILIndiana University· Indianapolis, INDana-Farber Cancer Institute· Boston, MAUniversity of Pennsylvania· Philadelphia, PAVanderbilt University· Nashville, TN

Related Studies