PALAVY Clinical Trial for Early-Stage Breast Cancer
Trial details
Overview: The PALAVY (Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer) trial is testing if the malaria drug Plaquenil (chemical name: hydroxychloroquine) or the immunotherapy drug Bavencio (chemical name: avelumab), with or without the targeted therapy Ibrance (chemical name: palbociclib, can prevent breast cancer from coming back in a part of the body away from the breast (metastatic recurrence).
Phase: Phase II; Phase II trials study whether a treatment is effective against cancer and determine common side effects and risks.
Number of people to enroll: 96
ClinicalTrials.gov ID number: NCT04841148
Sponsor of the trial: Abramson Cancer Center at Penn Medicine
Collaborators:
Johns Hopkins University
Translational Breast Cancer Research Consortium
Pfizer
Breast Cancer Research Foundation
Who is the trial for?
The PALAVY trial is enrolling people diagnosed with stage II or stage III estrogen receptor-positive, HER2-negative breast cancer who have completed the main treatments for breast cancer (surgery, chemotherapy, and radiation) and are taking hormonal therapy. They must have dormant breast cancer cells in their bone marrow. (People participating in the study will undergo a bone marrow aspiration procedure to assess this.)
Why is the trial being done?
The PALAVY trial is designed to see if the malaria drug hydroxychloroquine or Bavencio, with or without Ibrance, can prevent metastatic recurrence.
Dormant breast cancer cells can become active again years or even decades after the main treatments for breast cancer are completed. Research shows that people who have dormant cancer cells in their bone marrow after completing the main treatments have a higher risk of developing metastatic breast cancer.
Bavencio is approved by the U.S. Food and Drug Administration (FDA) to treat certain types of Merkel cell carcinoma, a type of skin cancer, and bladder cancer.
The three medicines being studied in the trial target dormant cancer cells in the bone marrow in different ways. The goal is to destroy the dormant cells before they reactivate.
In the study, people will be randomly assigned to one of four groups:
One group will take hydroxychloroquine by mouth, two times a day for six 28-day cycles.
The second group will receive Bavencio by IV, on day 1 and day 15 for six 28-day cycles.
The third group will receive Bavencio by IV, on day 1 and day 15, along with taking Ibrance by mouth on days 1 through 21, for six 28-day cycles.
The fourth group will receive hydroxychloroquine by mouth, two times a day, along with Ibrance by mouth on days 1 through 21, for six 28-day cycles.
Specific eligibility requirements
People are eligible for the PALAVY study if they:
have been diagnosed with stage II or stage III, estrogen receptor-positive, HER2-negative invasive breast cancer
have completed main breast cancer treatments (such as surgery, chemotherapy, and radiation).
have no evidence of recurrent or metastatic breast cancer
are taking hormonal therapy
have dormant breast cancer cells in their bone marrow
Learn about the additional eligibility requirements.
People are not eligible for this study if they:
have had an earlier invasive breast cancer diagnosis
have received high doses of steroids or other immunosuppressive medicines
have any severe or uncontrolled conditions such as an autoimmune disease, certain heart problems, lung disease or severely impaired lung function, or uncontrolled diabetes
Learn about the additional exclusion criteria.
Side effects
The most common side effects of hydroxychloroquine include:
ringing in ears
The most common side effects of Bavencio include:
The most common side effects of Ibrance include:
Study locations
This study is being conducted at seven sites across the United States:
Washington, DC
Chicago, IL
Indianapolis, IN
Boston, MA
Philadelphia, PA
Nashville, TN
Seattle, WA
For a complete list of sites, visit: https://clinicaltrials.gov/study/NCT04841148#contacts-and-locations
For more information or to enroll
Call Lauren Bayne, PhD at 215-349-5398 or email lajesse@pennmedicine.upenn.edu
Backup contact: Pauleen Sanchez, email pauleen.sanchez@pennmedicine.upenn.edu
— Last updated on September 15, 2024 at 2:40 PM