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Radiation Therapy
Short-Course Radiation for Breast Cancer (TRIO Trial)
N/A
Recruiting
Led By Muriel Brackstone, MD PhD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Plan to be treated with neoadjuvant chemotherapy
Invasive mammary carcinoma of any subtype excluding lobular, sarcomatous, or metaplastic subtypes, or with lobular features
Timeline
Screening 3 weeks
Treatment Varies
Follow Up disease status will be evaluated at routine patient follow-up appointments, including yearly mammography. will be reported at year 3.
Awards & highlights
TRIO Trial Summary
This trial is testing whether giving radiation in three fractions to high-risk breast cancer patients before standard of care treatment (neoadjuvant chemotherapy and surgery) can help the patients' immune system better fight the cancer.
Who is the study for?
This trial is for adults over 18 with high-risk, non-inflammatory breast cancer at stages IIB-III (IIA if triple negative or HER2-positive). Participants must be able to undergo MRI scans, tolerate needle biopsies, and have not received prior treatment for their current breast cancer. They should also plan to receive standard neoadjuvant chemotherapy.Check my eligibility
What is being tested?
The study tests whether three fractions of radiation before standard care can prime the immune system in patients with advanced breast cancer. The primary goal is to see if this leads to a complete response where no signs of cancer are found after treatment.See study design
What are the potential side effects?
Potential side effects may include skin reactions at the radiation site, fatigue, discomfort from positioning during treatment sessions, and typical risks associated with radiotherapy such as tissue damage.
TRIO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for chemotherapy before surgery.
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My breast cancer is not lobular, sarcomatous, metaplastic, or has lobular features.
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I am 18 years old or older.
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My cancer has not spread to other parts of my body.
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I can undergo needle biopsies without severe issues.
TRIO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ disease status will be evaluated at routine patient follow-up appointments, including yearly mammography. will be reported at year 3.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease status will be evaluated at routine patient follow-up appointments, including yearly mammography. will be reported at year 3.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic complete response
Secondary outcome measures
Ability of imaging markers to predict response to radiotherapy
Ability of imaging to predict patient response to radiotherapy.
Ability to predict pathological response to treatment based on tumour genetics
+6 moreTRIO Trial Design
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant radiotherapyExperimental Treatment1 Intervention
3 doses of stereotactic radiotherapy administered prior to neoadjuvant chemotherapy in high-risk breast cancers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neoadjuvant radiotherapy
2016
Completed Early Phase 1
~90
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
664 Previous Clinical Trials
414,040 Total Patients Enrolled
7 Trials studying Breast Cancer
260 Patients Enrolled for Breast Cancer
Muriel Brackstone, MD PhDPrincipal InvestigatorLondon Health Sciences Centre/Lawson Health Research Institute
Michael Lock, MDStudy ChairLondon Health Sciences Centre/London Regional Cancer Program
2 Previous Clinical Trials
110 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for chemotherapy before surgery.You cannot handle having a core needle biopsy.My breast cancer is at an advanced stage but not the most severe form.My breast cancer is not lobular, sarcomatous, metaplastic, or has lobular features.I am 18 years old or older.You are able to have an MRI scan.My cancer has not spread to other parts of my body.I can undergo needle biopsies without severe issues.I have health conditions that prevent me from receiving standard cancer treatments.I can't lay face down with my arms over my head for long.I am younger than 18 years old.I have received treatment for my current breast cancer.I have had radiation therapy on the same breast before.I have cancer in both of my breasts.I have not had any cancer other than non-melanoma skin cancer in the last 5 years.My breast cancer is inflammatory.My breast cancer is of a specific type, including lobular or with certain features.My breast cancer has come back.I cannot have an MRI due to size or other issues.My cancer has spread to distant parts of my body.I have a collagen vascular disease like lupus or scleroderma.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant radiotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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