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Clinical Trials in Canada / NCT03978663
Active, not recruiting Not applicable

Three Fraction Radiation to Induce Immuno-Oncologic Response

NCT03978663 · tracked via the Priya Life Science Canada tracker
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase
Not applicable
Started
2020-09-02
Last updated
2026-02-20

Condition(s) studied

High-Risk CancerLocally Advanced Breast Cancer

Investigational drug(s) / intervention(s)

Neoadjuvant radiotherapy

Neoadjuvant radiotherapy: Neoadjuvant radiation therapy delivered to a portion of the index tumour for high-risk breast carcinoma for immune priming prior to neoadjuvant radiation

Study summary

Patients with high risk breast cancers (any locally advanced breast cancer patient defined as Stages IIB-III \[excluding inflammatory breast cancer\] with stage IIA being eligible for triple negative and HER2-positive breast cancers) will receive neoadjuvant radiation to any portion of their tumour in three fractions in order to act as an immune primer. Radiation will be delivered to a portion of the tumour in three fractions. The patient will be positioned prone as per the SIGNAL 2.0 protocol. The patient will then go on to standard of care treatment (neoadjuvant chemotherapy and surgery) followed by whole-breast radiation as needed. Pathologic complete response will be the primary outcome. Immune markers will also be evaluated.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Any biopsy-proven locally advanced breast cancer patient defined as Stages IIB-III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2-positive breast cancers 2. Invasive mammary carcinoma of any subtype excluding lobular, sarcomatous, or metaplastic subtypes, or with lobular features 3. Plan to be treated with neoadjuvant chemotherapy 4. Able to fit in/have MRI 5. 18 years of age or older 6. Able to tolerate core needle biopsies 7. Able to provide informed consent 8. No evidence of metastatic disease Exclusion Criteria: 1. Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery 2. Prior treatment for current breast cancer 3. Previous radiation therapy to the same breast 4. Inflammatory breast carcinoma 5. Invasive lobular carcinoma or invasive mammary carcinoma with lobular, sarcomatous, or metaplastic subtypes, or with lobular features 6. Recurrent breast cancer 7. Bilateral breast cancer 8. Evidence of distant metastatic disease 9. Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis, psoriatic arthritis) 10. Any other malignancy at any site (except non-melanomatous skin cancer) \<5 years prior to study enrollment 11. Inability to lay prone with arms above the head for extended periods of time 12. Inability to fit in/have an MRI 13. Inability to tolerate core needle biopsies 14. Pregnant or lactating 15. Under 18 years of age 16. Inability or unwillingness to provide informed consent

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
London Regional Cancer Program London Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03978663 on ClinicalTrials.gov ↗ ← All trials in Canada