Immunotherapy + Chemotherapy for Breast Cancer
Trial Summary
What is the purpose of this trial?
This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced HER2-negative breast cancer. The primary efficacy objective is to determine if the immunotherapy increases the presence and percentage of tumor and/or stromal area of infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. At enrollment, patients will be assigned to one of 2 cohorts based on hormone receptor status.* Cohort A - patients with HER2-negative, hormone receptor-negative breast cancer (defined as both ER and PgR with \< 10% positive staining on IHC) Note: before beginning standard neoadjuvant chemotherapy, patients in Cohort A may be reassigned to Cohort A2 to receive extended pembrolizumab as part of new standard neoadjuvant and postoperative adjuvant therapy.* Cohort B - patients with HER2-negative, hormone receptor-positive breast cancer (defined as either ER or PgR with ≥ 10% positive staining on IHC)
Research Team
Harry D. Bear, M.D., Ph.D.
Principal Investigator
Massey Cancer Center
Eligibility Criteria
This trial is for adults over 18 with locally advanced HER2-negative breast cancer, either hormone receptor-positive or negative. Participants must not be pregnant, agree to contraception, and have proper liver, kidney, and bone marrow function. Exclusions include recent live vaccines, certain heart diseases, immunodeficiencies like HIV, active hepatitis B or C infections, prior treatments for current breast cancer diagnosis or other cancers within the last five years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Immunotherapy
Participants receive decitabine followed by pembrolizumab to increase lymphocyte infiltration into tumor and/or stroma
Neoadjuvant Chemotherapy
Participants receive 4 cycles of dose-dense doxorubicin and cyclophosphamide (AC), followed by 12 doses of weekly paclitaxel or Nab-paclitaxel
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of adverse events and response rates
Treatment Details
Interventions
- Carboplatin
- Cyclophosphamide
- Decitabine
- Paclitaxel
- Pembrolizumab
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
National Cancer Institute (NCI)
Collaborator