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Particle Therapy

Proton Beam vs X-ray Radiation Therapy for Breast Cancer

Phase 3

Recruiting

Led By Carlos E. Vargas, M.D.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post-radiation therapy

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complication rate

Secondary outcome measures

Cause-specific survival

Disease-free survival

Incidence of acute adverse events

+4 more

Other outcome measures

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,766,994 Total Patients Enrolled

83 Trials studying Breast Cancer

13,912 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,502 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Carlos E. Vargas, M.D.Principal InvestigatorMayo Clinic

5 Previous Clinical Trials

283 Total Patients Enrolled

Media Library

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for this research trial?

"This clinical trial, posted on June 8th 2020 and recently updated May 31st 2022, is now searching for participants."

Answered by AI

What potential hazards are related to the utilization of X-ray Therapy?

"With the evidence we have gathered, X-ray Therapy has been assigned a safety rating of 2. This is because Phase 2 trials provide us with some assurance as to its security, yet there are no studies explicitly attesting to its efficacy."

Answered by AI

How many participants are expected to join this investigation?

"This clinical research necessitates 98 individuals who are eligible for participation based on the stipulated inclusion criteria. Two sites, Mayo Clinic in Arizona located in Scottsdale and Mayo Clinic in Florida situated in Jacksonville are among those hosting this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase III Study of 5tx vs 15tx of RT (X-rays or Protons) Including RNI in Breast Cancer Patients

Carlos E. Vargas 2020. "Phase III Study of 5tx vs 15tx of RT (X-rays or Protons) Including RNI in Breast Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04443413.

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