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Radiation

Ultrahypofractionation Radiation Therapy for Breast Cancer

N/A

Recruiting

Led By Rachel Jimenez, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age

Be older than 18 years old

Must not have

Contra-indication to gadolinium contrast (e.g., chronic kidney disease)

Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 13 months (pre-treatment period to 12 month follow up)

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how PBT may reduce cardiac changes in breast cancer patients compared to XRT.

Who is the study for?

This trial is for adults over 18 with non-metastatic left-sided breast cancer needing radiation, including internal mammary lymph nodes treatment. It's also open to right-sided or unfavorable cardiac anatomy cases as determined by the study lead. Pregnant/breastfeeding individuals, those with conditions like scleroderma or chronic kidney disease, and patients on other investigational studies evaluating cardiac toxicity are excluded.

What is being tested?

The study compares two types of radiation therapy for breast cancer: Proton Beam Radiation Therapy (PBT) and Conventional Photon Radiation Therapy (XRT). The goal is to see if PBT causes fewer heart changes than XRT in patients with left-sided breast cancer, using MRI imaging for assessment.

What are the potential side effects?

Potential side effects include skin reactions at the treatment site, fatigue, swelling in treated areas, and possible heart changes detectable by MRI. Both PBT and XRT may have unique impacts on heart health which this trial aims to investigate.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

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

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I cannot have gadolinium contrast due to a health condition like kidney disease.

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I cannot receive radiotherapy due to certain health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 13 months (pre-treatment period to 12 month follow up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 13 months (pre-treatment period to 12 month follow up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 months (pre-treatment period to 12 month follow up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Myocardial Fibrosis from Baseline in Proton Beam Radiation Therapy (PBT)

Secondary study objectives

Body Image Evaluation

Change in Global Longitudinal Strain (GLS) on CMR from Baseline

Change in Shoulder Function from Baseline

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Accelerated Proton Beam Radiation Therapy (PBT) GroupExperimental Treatment1 Intervention

Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete: * Cardiac MRI and blood tests within 1 month prior to start of radiation therapy. * Radiation therapy 1x daily for 5 days over 1 week. * End of radiation therapy visit with blood tests. * 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging. * 12 month follow up visit with questionnaires and photographic imaging.

Group II: Accelerated Photon Radiation Therapy (XRT) GroupExperimental Treatment1 Intervention

0 / 3Eligibility criteria met