NCT03978663Active, not recruiting
Three Fraction Radiation to Induce Immuno-Oncologic Response
Evaluating the Use of Stereotactic Radiation Therapy Prior to Neoadjuvant Chemotherapy for High-risk Breast Carcinoma (a SIGNAL Series Clinical Trial): Three Fraction Radiation to Induce Immuno-Oncologic Response (TRIO Trial)
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 1 Jun 2019
- Start date
- 2 Sept 2020
- Primary completion date
- Jul 2026
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Metastatic breast cancer
- NCT number
- NCT03978663
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 2 Sept 2020 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery
- Prior treatment for current breast cancer
- Previous radiation therapy to the same breast
- Any other malignancy at any site (except non-melanomatous skin cancer) \<5 years prior to study enrollment
Other illness
- Recurrent breast cancer
- Bilateral breast cancer
- Evidence of distant metastatic disease
- Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis, psoriatic arthritis)
Age
- Under 18 years of age
Other
- Inflammatory breast carcinoma
- Invasive lobular carcinoma or invasive mammary carcinoma with lobular, sarcomatous, or metaplastic subtypes, or with lobular features
- Inability to lay prone with arms above the head for extended periods of time
- Inability to fit in/have an MRI
- Inability to tolerate core needle biopsies
- Pregnant or lactating
- Inability or unwillingness to provide informed consent
Who the study is looking for
- 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
- Invasive mammary carcinoma of any subtype excluding lobular, sarcomatous, or metaplastic subtypes, or with lobular features
- Plan to be treated with neoadjuvant chemotherapy
- Able to fit in/have MRI
- 18 years of age or older
- Able to tolerate core needle biopsies
- Able to provide informed consent
- No evidence of metastatic disease
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Regional Cancer Program Coordinator of this site? Confirm its status | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.