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Proton Beam Therapy

Shorter Course Proton Therapy for Breast Cancer

Phase 2
Waitlist Available
Led By Robert W Mutter
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status (PS) 0 to 2
pStage T1-T4N0-N3M0 or ypStage T0-4N0-N3M0. Note: The axilla must be staged by sentinel node biopsy alone, sentinel node biopsy followed by axillary node dissection, or axillary lymph node dissection alone
Must not have
Boosts to the chest wall after mastectomy. Nodal boosts are allowed
Medical contraindication to receipt of radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 years, and 5 years
Awards & highlights

Summary

This trial is comparing different schedules of a precise radiation treatment for patients who have had breast removal surgery and need radiation to their lymph nodes. This treatment targets cancer cells precisely, reducing harm to healthy tissues. This method has been proposed to improve the long-term quality of life of breast cancer patients by reducing the dose to healthy tissue compared to traditional methods.

Who is the study for?
This trial is for adults over 18 with breast cancer who've had a mastectomy and need radiation to the lymph nodes. They should be in good enough health to consent, not pregnant, able to complete questionnaires, provide samples for research, and return for follow-up. Those with severe illnesses or conditions that could affect study results or safety are excluded.
What is being tested?
The trial tests two different schedules of proton radiotherapy after mastectomy: one using 15 treatments (fractions) and another using 25 fractions. It's randomized, meaning patients are put into groups by chance to compare the safety of these two approaches.
What are the potential side effects?
Potential side effects from proton radiotherapy can include skin reactions at the treatment site, fatigue, changes in skin coloration or texture, swelling due to fluid buildup (lymphedema), and less commonly heart or lung issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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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My breast cancer is at a specific stage and my underarm lymph nodes were checked.
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I am 18 years old or older.
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I had breast cancer surgery and will receive radiation on my chest and nearby lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received or will receive extra radiation to my chest wall after mastectomy.
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I cannot receive radiotherapy due to health reasons.
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I have active systemic lupus or scleroderma.
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I have been diagnosed with inflammatory breast cancer.
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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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I am pregnant or not using birth control while being able to conceive.
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I have had radiation on the same side as my current treatment but not on the opposite side.
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My breast cancer has come back after treatment.
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I haven't had any cancer other than breast cancer in the last 5 years.
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Cancer cells were found at the edge of the tissue removed during my last surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 years, and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 years, and 5 years 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, defined as grade 3 or greater late adverse events and unplanned surgical intervention in patients who undergo mastectomy with reconstruction
Secondary study objectives
Cosmesis
Disease-free Survival (DFS)
Distant Recurrence Incidence
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HypofractionationExperimental Treatment1 Intervention
40 Gy (RBE) in 15 daily fractions
Group II: Conventional FractionationActive Control1 Intervention
50.0 Gy (RBE) in 25 daily fractions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionation
2017
Completed Phase 2
~550

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pencil Beam Scanning Proton Radiotherapy is a form of targeted radiation therapy that uses protons to deliver high doses of radiation directly to the tumor while minimizing damage to surrounding healthy tissues. This precision is particularly important for breast cancer patients requiring regional nodal irradiation after mastectomy, as it reduces the risk of side effects and damage to critical structures such as the heart and lungs. Other common treatments for breast cancer include surgery (to remove the tumor), chemotherapy (to kill cancer cells throughout the body), hormone therapy (to block hormones that fuel certain types of breast cancer), and targeted therapy (to attack specific cancer cell mechanisms). The choice of treatment depends on the cancer's stage, type, and individual patient factors, aiming to maximize efficacy while minimizing adverse effects.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,357 Total Patients Enrolled
83 Trials studying Breast Cancer
14,708 Patients Enrolled for Breast Cancer
Robert W MutterPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
42 Total Patients Enrolled
Robert W. Mutter, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
400 Total Patients Enrolled
1 Trials studying Breast Cancer
400 Patients Enrolled for Breast Cancer

Media Library

Pencil Beam Scanning Proton Radiotherapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02783690 — Phase 2
Breast Cancer Clinical Trial 2023: Pencil Beam Scanning Proton Radiotherapy Highlights & Side Effects. Trial Name: NCT02783690 — Phase 2
~9 spots leftby Sep 2025
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