NCT07188246RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 4 May 2023
- Start date
- Jan 2026
- Primary completion date
- Jul 2027
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07188246
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From Jan 2026 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Age
- Under 18 years of age.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Joseph's Health Care London Coordinator of this site? Confirm its status | London | Canada | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.