← Back to Search

Pembrolizumab + Radiation for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Stephen Shiao, MD, PHD
Research Sponsored by Stephen Shiao
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ER, PR and HER2 testing (on outside or Cedars-Sinai biopsy report)
Any nodal status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to one year post-treatment
Awards & highlights

Study Summary

This trial is testing if pembrolizumab can be safely given with a tumor boost and if it helps the standard treatment work better.

Who is the study for?
This trial is for adults with invasive breast cancer, specifically high-risk ER-positive/HER2-negative or triple-negative types without distant metastases. Participants must have a tumor ≥2 cm, be willing to undergo biopsies and adhere to the study schedule. It excludes those with certain cosmetic breast augmentations, other active cancers within 3 years, inflammatory breast cancer, contraindications to radiation therapy or breast-conserving therapy, known HIV/Hepatitis B/C infections, uncontrolled medical disorders or active autoimmune diseases.Check my eligibility
What is being tested?
The trial tests pembrolizumab (an immunotherapy drug) combined with a 'tumor boost' of radiation before standard treatments like surgery or chemotherapy. Patients will receive two doses of pembrolizumab three weeks apart; during the second dose they'll also get radiation. Surgery or chemotherapy starts about six weeks after the first dose.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions and potential infusion-related reactions. Radiation can lead to skin changes at the treatment site and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has been tested for ER, PR, and HER2.
Select...
My cancer may or may not have spread to the lymph nodes.
Select...
I am fully active or can carry out light work.
Select...
I am planning to have surgery that will not remove my entire breast.
Select...
I have cancer in both breasts at the same time.
Select...
My largest cancer area is at least 2 cm big.
Select...
I am using approved birth control methods and have had a negative pregnancy test.
Select...
I am willing to have a biopsy for research in 4 weeks.
Select...
I have been diagnosed with invasive breast cancer.
Select...
My cancer has not spread to distant parts of my body.
Select...
My tumor can be treated with an extra dose of radiation before surgery, as advised by my radiation oncologist.
Select...
My tumor is at least 2 cm big and can be operated on.
Select...
I have triple-negative breast cancer.
Select...
My breast cancer is high-risk, ER-positive, and HER2-negative.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to one year post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to one year post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Tumor Infiltrating Lymphocytes (TIL)
Number of Patients Who do Not Necessitate a Delay in Standard of Care Treatment After Receiving the Investigational Combination of Preoperative Pembrolizumab and Radiation
Secondary outcome measures
Immune-related Adverse Events
Invasive Disease-free Survival After Preoperative Radiation and Pembrolizumab
Pathological Complete Response Rate
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab with RT BoostExperimental Treatment2 Interventions
Study drug plus "tumor boost" before standard of care treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Stephen ShiaoLead Sponsor
1 Previous Clinical Trials
35 Total Patients Enrolled
1 Trials studying Breast Cancer
35 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
856 Previous Clinical Trials
225,529 Total Patients Enrolled
36 Trials studying Breast Cancer
3,400 Patients Enrolled for Breast Cancer
Stephen Shiao, MD, PHDPrincipal Investigator - Cedars-Sinai Medical Center
Cedars-Sinai Medical Center, Westside Radiation Oncology Medical Group Inc
Yale University School Of Medicine (Medical School)

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT03366844 — Phase 1 & 2
Breast Cancer Research Study Groups: Pembrolizumab with RT Boost
Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03366844 — Phase 1 & 2
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03366844 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies has Pembrolizumab been prescribed to alleviate?

"Pembrolizumab has a wide range of clinical applications, especially in the oncology field. Patients with unresectable melanomas, high microsatellite instability and disease progression after chemotherapy can benefit from its use."

Answered by AI

What additional research has been conducted related to Pembrolizumab?

"Presently, there are 961 ongoing trials researching pembrolizumab's efficacy, with 122 of these studies currently in Phase 3. With 35731 locations conducting clinical research for this drug, Houston stands out as the primary centre for Pembrolizumab testing."

Answered by AI

What is the number of enrollees in this medical experiment?

"This research study is no longer recruiting patients. Initially published on December 22nd, 2017 and last amended on April 15th 2022, this trial has concluded its search for participants. However, if you are seeking alternative studies to join there are currently 2,600 clinical trials admitting those affected by breast cancer and 961 medical investigations taking part in pembrolizumab treatment actively looking for volunteers."

Answered by AI

What are the objectives of this medical experiment?

"The primary aim of this study, monitored over an 8 week period post initiation, is to establish the number of patients who do not require a delay in their standard care treatment after receiving preoperative Pembrolizumab and radiation therapy. Secondary objectives include evaluating invasive disease-free survival following preoperative radiotherapy and pembrolimzumab; noting any treatment-related adverse events; as well as determining the pathological complete response rate - i.e., absence of invasive cancer cells within breast tissue or lymph nodes prior to surgical intervention."

Answered by AI

Are individuals currently being accepted to take part in this research?

"Based on the information posted to clinicaltrials.gov, this research trial is not currently open for new volunteers. The study was initially published in December 2017 and edited most recently in April 2022; however, with 3561 other trials actively recruiting right now there are plenty of opportunities to get involved with medical research."

Answered by AI
~9 spots leftby Mar 2025