Status:
NOT_YET_RECRUITING
Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Breast Cancer
Breast Cancer Stage II
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ne...
Detailed Description
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...
Eligibility Criteria
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.
- a. 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
- Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery (e.g., uncontrolled diabetes, serious heart condition, etc).
- Prior treatment for current breast cancer.
- Previous radiation therapy to the same breast.
- Inflammatory breast carcinoma.
- Invasive mammary carcinoma with sarcomatous, signet cell or metaplastic subtypes.
- 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).
- No prior stem cell transplantation.
- Any poorly controlled autoimmune conditions.
- 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.
- Inability to tolerate core needle biopsies or pembrolizumab injection.
- Pregnant or lactating.
- Under 18 years of age.
- Inability or unwillingness to provide informed consent.
- Inability or unwillingness to complete study assessments/interventions and follow-up assessments.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07188246
Start Date
October 1 2025
End Date
January 1 2029
Last Update
September 23 2025
Active Locations (2)
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1
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
2
London Regional Cancer Program
London, Ontario, Canada