Actively Recruiting
Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2026-02-11
40
Participants Needed
2
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the immune-priming effects of stereotactic body radiation therapy (SBRT) regimen coupled with two injections of pembrolizumab in high-risk primary breast carcinoma prior to neoadjuvant chemotherapy. Preliminary results from the investigators' local TRIO Trial suggest that SBRT prior to neoadjuvant chemotherapy (NAC) may result in improved response rates due to the combined effect of radiation therapy (RT) and chemotherapy. The investigators aim to augment this effect with the addition of pembrolizumab, a monoclonal antibody that binds to and blocks programmed cell death protein 1 (PD-1).
CONDITIONS
Official Title
Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with invasive ductal carcinoma of any subtype except sarcomatous, signet, or metaplastic subtypes
- Breast cancer stage IIB to III; stage IIA allowed if triple negative or HER2 positive
- Tumor is palpable by treating physician
- Plan to receive neoadjuvant chemotherapy
- Able to tolerate core needle biopsies and pembrolizumab injections
- At least 18 years old
- Able to provide informed consent
You will not qualify if you...
- Serious medical conditions or contraindications to radiotherapy, chemotherapy, or surgery
- Prior treatment for current breast cancer
- Previous radiation therapy to the same breast
- Inflammatory breast carcinoma
- Invasive mammary carcinoma with sarcomatous, signet cell, or metaplastic subtypes
- Recurrent breast cancer
- Evidence or suspicion of distant metastatic disease
- Collagen vascular diseases preventing radiotherapy (e.g., lupus, scleroderma)
- Prior stem cell transplantation
- Poorly controlled autoimmune conditions
- Current use of corticosteroids or immunosuppressants
- Other malignancies within 5 years except non-melanoma skin cancer
- Unable to tolerate core needle biopsies or pembrolizumab injections
- Pregnant or breastfeeding
- Under 18 years old
- Unable or unwilling to provide informed consent
- Unable or unwilling to complete study assessments and follow-up
AI-Screening
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Trial Site Locations
Total: 2 locations
1
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
Not Yet Recruiting
2
St. Joseph's Health Care London
London, Ontario, Canada
Actively Recruiting
Research Team
M
Muriel Brackstone, MD, PhD
CONTACT
K
Kalan S Lynn, M. Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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