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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)
ECOG performance status score of 0 or 1
Must not have
HER2-positive breast cancer defined as IHC3+ or IHC2+ with FISH>2 AND copy number >4 OR FISH <2 AND copy number >6
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to one year post-treatment
Awards & highlights
No Placebo-Only Group

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.
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.
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
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My cancer has been tested for ER, PR, and HER2.
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I am fully active or can carry out light work.
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I am planning to have surgery that will not remove my entire breast.
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I have cancer in both breasts at the same time.
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I am willing to have a biopsy for research in 4 weeks.
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I have been diagnosed with invasive breast cancer.
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My cancer has not spread to distant parts of my body.
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My tumor can be treated with an extra dose of radiation before surgery, as advised by my radiation oncologist.
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My tumor is at least 2 cm big and can be operated on.
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My breast cancer is high-risk, ER-positive, and HER2-negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer is HER2-positive based on specific test results.
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I have an immune system disorder or am on long-term steroids.
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I have another cancer that is getting worse or was treated in the last 3 years.
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I am currently on medication for an infection.
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I cannot have breast-conserving therapy due to specific health reasons.
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I have breast implants that were in place before my cancer diagnosis.
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I have been treated for an autoimmune disease in the last 2 years.
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I have a history of HIV, Hepatitis B, or Hepatitis C.
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I am not currently on any treatments that are not allowed in this study.
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I have been diagnosed with inflammatory breast cancer.
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I cannot undergo radiation therapy or am not planning to have partial breast irradiation.
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My cancer has spread to other parts of my body.
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I have had pneumonitis treated with steroids or currently have it.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~3150

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
910 Previous Clinical Trials
333,665 Total Patients Enrolled
37 Trials studying Breast Cancer
103,278 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
~0 spots leftby Dec 2024
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