RecruitingPhase 2NCT07188246

Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer

A Trial of Neoadjuvant, Hypofractionated Radiation, With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy, in Stage 3 or High-risk Stage 2 Breast Cancer

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrollment

40 participants

Start Date

Jan 19, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Cancer Stage II Breast Cancer Invasive Breast Cancer Stage III Breast Cancer Triple Negative

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding focused radiation (SBRT) and a direct injection of an immunotherapy drug (pembrolizumab) into the tumor before standard chemotherapy can improve outcomes for people with breast cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with invasive breast cancer at stage IIB or higher (or stage IIA if triple-negative or HER2-positive) - Your tumor can be felt by your doctor - You are already planning to receive chemotherapy before surgery **You may NOT be eligible if...** - You have inflammatory breast cancer - Your breast cancer has already spread to other parts of the body - You have had prior radiation to the same breast - You have a serious autoimmune disease such as lupus or scleroderma - You are currently on steroids or immune-suppressing medications - You have had another cancer in the past 5 years (except certain skin cancers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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