CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 66 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03366844
NCT03366844Phase 2Active

Preoperative Combination of Pembrolizumab and Radiation Therapy in Patients With Operable Breast Cancer

Stephen Shiao·interventional·Posted Dec 8, 2017·Updated Apr 20, 2026

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and RT Boost for Breast Cancer. Active but no longer recruiting, targeting 66 participants across 1 site.

Detailed Summary

This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the following: breast-conserving surgery, radiation to the entire breast/chest wall after surgery, and chemotherapy. Study participants will receive two doses of the study drug intravenously (through the vein) before their planned breast surgery or chemotherapy. The study drug will be administered three weeks apart. At the time of the second dose, radiation to the tumor in the affected breast will be given. This type of radiation treatment is called a "tumor boost", which is a standard part of radiation therapy for breast cancer that may occur either before or after planned breast-conserving surgery. Patients will receive breast surgery or begin chemotherapy approximately six weeks after your first dose of the study drug.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2Active
20182019202020212022202320242025202620272028202920302031
First PostedDec 8, 2017
Enrollment StartDec 22, 2017
Primary CompletionFeb 6, 2025
Study CompletionDec 7, 2030
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 8.6 years ago

Interventions

Pembrolizumabdrug

checkpoint inhibitor

RT Boostradiation

The second dose of pembrolizumab will be given in conjunction with an RT boost, consisting of 8 Gy for 3 fractions.