120
Participants
Start Date
December 16, 2020
Primary Completion Date
August 8, 2025
Study Completion Date
August 31, 2027
Radiation Therapy Boost
Participants randomized to the low-dose or high-dose RT boost group will be receiving treatment on Day 1-3 of Cycle 1 of pembrolizumab. Proton therapy may be used in the high dose RT group.
Pembrolizumab
"Neoadjuvant Phase: Day 1 (once every 6 weeks) of Cycles 1-4 (by intravenous infusion) over about 30 minutes.~Adjuvant Phase: Pembrolizumab may be given post-surgery for up to 4 cycles (once every 6 weeks) by intravenous infusion over about 30 minutes. Pembrolizumab after surgery is optional and should be discussed with the study doctor."
Paclitaxel
Starting Week 3 and administered once per week for 12 weeks (up to 12 doses) by intravenous infusion over about 30 minutes.
Carboplatin
"Carboplatin is optional for TNBC patients and should be discussed with the study doctor.~Starting Week 3 and administered once per week for 12 weeks (up to 12 doses) by intravenous infusion over about 30 minutes."
Cyclophosphamide
Starting Week 15 and administered every 2 weeks for 4 cycles (up to 4 doses) into your vein (by intravenous infusion).
Doxorubicin
Starting Week 15 and administered every 2 weeks for 4 cycles (up to 4 doses) into your vein (by intravenous infusion). Doxorubicin will be administered after pembrolizumab.
Capecitabine
"Capecitabine after surgery is optional for TNBC patients and should be discussed with the study doctor.~Starting 3-6 weeks after surgery, administered orally twice daily for 6 courses, each 3 weeks long (for a total of 18 weeks)."
Memorial Sloan Kettering Cancer Center, New York
Montefiore Medical Center, The Bronx
Sibley Memorial Hospital, Washington D.C.
Johns Hopkins, Baltimore
University of North Carolina Medical Center, Chapel Hill
Duke University Medical Center, Durham
Mayo Clinic - Rochester, Rochester
MD Anderson Cancer Center, Houston
Massachusetts General Hospital, Boston
Dana Farber Cancer Institute, Boston
Collaborators (1)
Merck Sharp & Dohme LLC
INDUSTRY
Breast Cancer Research Foundation
OTHER
Translational Breast Cancer Research Consortium
OTHER
Laura M. Spring, MD
OTHER