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Particle Therapy

Proton Beam vs X-ray Radiation Therapy for Breast Cancer

Phase 3

Recruiting

Led By Carlos E Vargas

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Clinical or pathologic T1-T4c, N0-3, M0 disease

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2

Must not have

No active metastatic disease from other origin

Active systemic lupus or scleroderma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post-radiation therapy

Awards & highlights

Summary

This trial is investigating whether proton beam radiation therapy has fewer complications than x-ray therapy in treating patients with breast cancer.

Who is the study for?

This trial is for adults over 18 with breast cancer who've had surgery to remove it. They should be in fair health (ECOG PS 0-2) and able to consent. It's not for those with recurrent cancer, other active metastatic diseases, severe illnesses that could affect the study, or men. Pregnant women and patients needing bilateral radiation are also excluded.

What is being tested?

The trial compares complications from two types of radiation therapy after breast surgery: x-ray therapy or proton beam therapy given over either 5 or more than 15 sessions. The goal is to see which treatment frequency has fewer complications when treating regional lymph nodes.

What are the potential side effects?

Potential side effects include skin changes, fatigue, pain at the site of treatment, swelling due to fluid buildup (lymphedema), heart and lung issues related to radiation exposure, and a slight risk of developing another type of cancer.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is in stages T1-T4c, N0-3, M0.

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I can take care of myself and am up and about more than half of my waking hours.

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I have had surgery to remove my breast cancer, with or without reconstruction.

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I am 18 years old or older.

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My breast cancer has been confirmed by tissue analysis.

Exclusion Criteria

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

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My cancer has not spread from another part of my body.

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I have active systemic lupus or scleroderma.

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My surgery for breast cancer left some cancer cells at the edge of the removed tissue.

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I need radiation treatment for both of my breasts.

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I have had radiation therapy on the same side breast or chest before.

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I cannot undergo radiotherapy due to health reasons.

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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My breast cancer has come back.

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My condition is inflammatory breast cancer.

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I am a male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post-radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post-radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-radiation therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Complication rate

Secondary study objectives

Cause-specific survival

Disease-free survival

Incidence of acute adverse events

+4 more

Other study objectives

Cosmetic outcome

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (proton beam radiation therapy)Experimental Treatment2 Interventions

Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo proton beam radiation therapy over 5 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may receive a concurrent 5-fraction boost of proton beam radiation therapy.

Group II: Arm I (x-ray therapy)Experimental Treatment2 Interventions

Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo x-ray therapy over 25 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may then receive a 4-fraction boost of x-ray therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,298 Previous Clinical Trials

3,958,299 Total Patients Enrolled

84 Trials studying Breast Cancer

14,796 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,854 Total Patients Enrolled

945 Trials studying Breast Cancer

1,543,964 Patients Enrolled for Breast Cancer

Carlos E VargasPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

76 Total Patients Enrolled

Media Library

Breast Cancer Research Study Groups: Arm I (x-ray therapy), Arm II (proton beam radiation therapy)

~20 spots leftby Jun 2025

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