Radiation with Pembrolizumab Before Chemotherapy for Breast Cancer
Tests radiation and pembrolizumab before chemotherapy in adults with advanced breast cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer
Key facts
- Where
- London, CanadaSee the site
- Phase
- Phase 2
Where in Canada
- St. Joseph's Health Care LondonLondon, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Trial code
- NCT07188246
- Record updated
- 11 February 2026
- Original description
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).Read full original descriptionShow less
A Trial of Neoadjuvant, Hypofractionated Radiation, With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy, in Stage 3 or High-risk Stage 2 Breast Cancer
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).
Inclusion: Invasive ductal carcinoma of any subtype (including invasive mammary carcinoma with lobular features), excluding sarcomatous, signet or metaplastic subtypes; Invasive mammary carcinoma of stages IIB - III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2+ breast cancers; Clinical staging based on AJCC 8th edition; Lesion palpable by treating physician; Plan to be treated with neoadjuvant chemotherapy; Able to tolerate core needle biopsies and pembrolizumab injection; 18 years of age or older; Able to provide informed consent.
Exclusion: Prior treatment for current breast cancer; Previous radiation therapy to the same breast; No prior stem cell transplantation; Current use of corticosteroids or immunosuppressants; Any other malignancy at any site (except non-melanomatous skin cancer) <5 years prior to study enrollment. Synchronous bilateral breast cancers are acceptable; Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery (e.g., uncontrolled diabetes, serious heart condition, etc); Recurrent breast cancer; Clinical or radiologic evidence or suspicion of distant metastatic disease (metastatic workup that requires additional imaging to follow-up on suspicious findings will exclude patients); Any collagen vascular disease precluding radiotherapy at the discretion of the treating radiation oncologist (particularly lupus, scleroderma, dermatomyositis, psoriatic arthritis); Any poorly controlled autoimmune conditions; Under 18 years of age; Inflammatory breast carcinoma; Invasive mammary carcinoma with sarcomatous, signet cell or metaplastic subtypes; Inability to tolerate core needle biopsies or pembrolizumab injection; Pregnant or lactating; Inability or unwillingness to provide informed consent; Inability or unwillingness to complete study assessments/interventions and follow-up assessments.