Triple threat: radiation and immunotherapy before chemotherapy may boost breast cancer response
NCT ID NCT07188246
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether giving a short course of radiation (SBRT) and two injections of the immunotherapy drug pembrolizumab (Keytruda) before standard chemotherapy can improve outcomes for people with stage 2 or 3 breast cancer. The study aims to see if this combination can prime the immune system to better attack the tumor, leading to a higher rate of complete cancer disappearance at the time of surgery. About 40 participants with high-risk breast cancer will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pembrolizumab (Keytruda) and stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, this approach could improve the chance of eliminating all cancer before surgery, potentially reducing recurrence risk.
- What could go wrong
- This is a small, early-phase trial (40 people) with no control group. The added radiation and immunotherapy may cause side effects like skin toxicity, and the benefit over standard chemotherapy alone is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Invasive ductal carcinoma of any subtype (including invasive mammary carcinoma with lobular features), excluding sarcomatous, signet or metaplastic subtypes. 2. Invasive mammary carcinoma of stages IIB - III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2+ breast cancers. a. Clinical staging based on AJCC 8th edition. 3. Lesion palpable by treating physician. 4. Plan to be treated with neoadjuvant chemotherapy. 5. Able to tolerate core needle biopsies and pembrolizumab injection. 6. 18 years of age or older. 7. Able to provide informed consent. Exclusion Criteria: 1. Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery (e.g., uncontrolled diabetes, serious heart condition, etc). 2. Prior treatment for current breast cancer. 3. Previous radiation therapy to the same breast. 4. Inflammatory breast carcinoma. 5. Invasive mammary carcinoma with sarcomatous, signet cell or metaplastic subtypes. 6. Recurrent breast cancer. 7. 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). 8. Any collagen vascular disease precluding radiotherapy at the discretion of the treating radiation oncologist (particularly lupus, scleroderma, dermatomyositis, psoriatic arthritis). 9. No prior stem cell transplantation. 10. Any poorly controlled autoimmune conditions. 11. Current use of corticosteroids or immunosuppressants. 12. Any other malignancy at any site (except non-melanomatous skin cancer) \<5 years prior to study enrollment. Synchronous bilateral breast cancers are acceptable. 13. Inability to tolerate core needle biopsies or pembrolizumab injection. 14. Pregnant or lactating. 15. Under 18 years of age. 16. Inability or unwillingness to provide informed consent. 17. Inability or unwillingness to complete study assessments/interventions and follow-up assessments.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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St. Joseph's Health Care London
NOT_YET_RECRUITINGLondon, Ontario, N6A 4V2, Canada
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St. Joseph's Health Care London
RECRUITINGLondon, Ontario, Canada
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