A Phase II Trial of Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer (PALAVY)
Abramson Cancer Center at Penn Medicine
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.
Description
The overarching goal of this clinical trial is to reduce the incidence of incurable recurrent metastatic breast cancer by targeting the precursors of these recurrences, bone marrow disseminated tumor cells (DTCs) present after definitive treatment. This trial targets unique mechanisms by which DTCs maintain a dormant phenotype (autophagy) and by which they escape dormancy (upregulation of the cyclin-dependent kinase4/6 (CDK4/6) pathway and microenvironmental factors such as immune evasion). The selection of these agents is based upon strong preclinical data demonstrating the relevance of autop…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Bone marrow aspirate after completion of all definitive therapy demonstrates detectable DTCs (via IHC) as performed by central laboratory assessment at University of Pennsylvania. * History of stage II-III histologically-confirmed ER+/Her2 neg invasive breast cancer with no evidence of recurrent local or distant disease (by American Joint Committee on Cancer 7th edition). Patients with bilateral breast cancer are eligible, so long as both cancers are ER+/Her2 neg, at least one meets other eligibility criteria and patient is treated with curative intent. For patients who…
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 UniversityWashington D.C., District of Columbia
- University of ChicagoChicago, Illinois
- Indiana UniversityIndianapolis, Indiana
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of PennsylvaniaPhiladelphia, Pennsylvania
- Vanderbilt UniversityNashville, Tennessee