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Three Fraction Radiation to Induce Immuno-Oncologic Response

NCT03978663 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-20

No results posted yet for this 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.

Conditions

  • High-Risk Cancer
  • Locally Advanced Breast Cancer

Interventions

RADIATION

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

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Muriel Brackstone, MD PhD · London Health Sciences Centre/Lawson Health Research Institute

  • Michael Lock, MD · London Health Sciences Centre/London Regional Cancer Program

  • Brian Yaremko, MD · London Health Sciences Centre/London Regional Cancer Program

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978663 on ClinicalTrials.gov