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

Summary

This research trial is studying a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer.

The names of the study interventions involved in this study are:

* Radiation Therapy (RT)
* Immunotherapy: Pembrolizumab (MK-3475)
* Chemotherapies:

* Paclitaxel
* Doxorubicin (also called Adriamycin)
* Cyclophosphamide
* Carboplatin (optional, and in TN only)
* Capecitabine (optional, and in TN only)

Conditions

• Triple Negative Breast Cancer
• Hormone Receptor Positive (HR+), HER2-negative Breast Cancer
• Biopsy-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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Breast Cancer Research Foundation

  collaborator OTHER

• Translational Breast Cancer Research Consortium

  collaborator OTHER

• Laura M. Spring, MD

  lead OTHER

Principal Investigators

• Laura M Spring, MD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-16

Primary Completion

2025-08-08

Completion

2027-08-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations