Pre-op Pembro + Radiation Therapy in Breast Cancer (P-RAD)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 16, 2020

Primary Completion Date

August 8, 2025

Study Completion Date

August 31, 2027

Conditions
Triple Negative Breast CancerHormone Receptor Positive (HR+), HER2-negative Breast CancerBiopsy-proven, Positive Lymph Node(s)
Interventions
RADIATION

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.

DRUG

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."

DRUG

Paclitaxel

Starting Week 3 and administered once per week for 12 weeks (up to 12 doses) by intravenous infusion over about 30 minutes.

DRUG

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."

DRUG

Cyclophosphamide

Starting Week 15 and administered every 2 weeks for 4 cycles (up to 4 doses) into your vein (by intravenous infusion).

DRUG

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.

DRUG

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)."

Trial Locations (10)

10065

Memorial Sloan Kettering Cancer Center, New York

10467

Montefiore Medical Center, The Bronx

20016

Sibley Memorial Hospital, Washington D.C.

21231

Johns Hopkins, Baltimore

27514

University of North Carolina Medical Center, Chapel Hill

27710

Duke University Medical Center, Durham

55905

Mayo Clinic - Rochester, Rochester

77030

MD Anderson Cancer Center, Houston

02115

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Breast Cancer Research Foundation

OTHER

collaborator

Translational Breast Cancer Research Consortium

OTHER

lead

Laura M. Spring, MD

OTHER