Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer
NCT ID: NCT07188246
Last Updated: 2026-02-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-01-19
Study Completion Date
2029-02-28
Brief Summary
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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).
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Detailed Description
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This study will evaluate the immune-priming effects of stereotactic body radiation therapy (SBRT) combined with intratumoural pembrolizumab in patients with high-risk primary breast carcinoma prior to neoadjuvant chemotherapy. Prior feasibility trials (SIGNAL and TRIO) demonstrated that neoadjuvant SBRT can upregulate immune-related genes, suggesting conversion of tumors toward an "immune hot" phenotype that may enhance responsiveness to immunotherapy.
The current trial builds on this work by adding pembrolizumab, an anti-PD-1 antibody, to determine whether further immune priming can be achieved. Study objectives include assessing feasibility, safety, molecular immune activation, and preliminary clinical outcomes of this regimen before standard chemotherapy.
SBRT is a highly targeted radiotherapy technique that has demonstrated feasibility in early and locally advanced breast cancer trials, with low toxicity. Pembrolizumab is approved for multiple cancers, including triple negative breast cancer, and may act synergistically with radiotherapy to enhance antitumor immune responses. Findings from this study will inform future randomized trials evaluating whether combining SBRT and immunotherapy can improve pathologic complete response rates and long-term outcomes in breast cancer.
The current trial builds on this work by adding pembrolizumab, an anti-PD-1 antibody, to determine whether further immune priming can be achieved. Study objectives include assessing feasibility, safety, molecular immune activation, and preliminary clinical outcomes of this regimen before standard chemotherapy.
SBRT is a highly targeted radiotherapy technique that has demonstrated feasibility in early and locally advanced breast cancer trials, with low toxicity. Pembrolizumab is approved for multiple cancers, including triple negative breast cancer, and may act synergistically with radiotherapy to enhance antitumor immune responses. Findings from this study will inform future randomized trials evaluating whether combining SBRT and immunotherapy can improve pathologic complete response rates and long-term outcomes in breast cancer.
Conditions
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Breast Cancer
Breast Cancer Stage II
Breast Cancer Stage III
Breast Cancer Invasive
Breast Cancer Triple Negative
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Single arm open-label study of breast SBRT with immunotherapy before neoadjuvant chemotherapy
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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SBRT with Pembrolizumab
Stereotactic body radiation therapy delivered to the main breast tumour with 2 injections of pembrolizumab (Keytruda), completed prior to neoadjuvant chemotherapy.
Group Type
EXPERIMENTAL
Radiation
Intervention Type
RADIATION
Stereotactic body radiation therapy to the breast
Pembrolizumab (KEYTRUDA®)
Intervention Type
DRUG
Two injections
Interventions
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Radiation
Stereotactic body radiation therapy to the breast
Intervention Type
RADIATION
Pembrolizumab (KEYTRUDA®)
Two injections
Intervention Type
DRUG
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Sponsor Role
lead
Responsible Party
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Muriel Brackstone
Chair/Chief of General Surgery, General Surgeon, Surgical Oncologist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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St. Joseph's Health Care London
London, Ontario, Canada
Site Status
NOT_YET_RECRUITING
St. Joseph's Health Care London
London, Ontario, Canada
Site Status
RECRUITING
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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122109
Identifier Type: -
Identifier Source: org_study_id
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Study of Pembrolizumab (MK-3475) Monotherapy for Metastatic Triple-Negative Breast Cancer (MK-3475-086/KEYNOTE-086)
NCT02447003
COMPLETED
PHASE2
Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer
NCT06914440
RECRUITING
PHASE2
TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer
NCT06532812
RECRUITING
PHASE1/PHASE2