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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

Must not have

Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery

Inability to lay prone with arms above the head for extended periods of time

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have health conditions that prevent me from receiving standard cancer treatments.

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I can't lay face down with my arms over my head for long.

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I am younger than 18 years old.

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I have received treatment for my current breast cancer.

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I have had radiation therapy on the same breast before.

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I have cancer in both of my breasts.

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I have not had any cancer other than non-melanoma skin cancer in the last 5 years.

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My breast cancer is inflammatory.

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My breast cancer is of a specific type, including lobular or with certain features.

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My breast cancer has come back.

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I cannot have an MRI due to size or other issues.

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My cancer has spread to distant parts of my body.

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I have a collagen vascular disease like lupus or scleroderma.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and disease status will be evaluated at routine patient follow-up appointments, including yearly mammography. will be reported at year 3. for reporting.