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Proton Beam Therapy
Shorter Course Proton Therapy for Breast Cancer
Phase 2
Waitlist Available
Led By Robert W. Mutter, 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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 years, and 5 years
Awards & highlights
Study Summary
This trial is testing whether a lower dose of proton therapy is just as effective as a higher dose for breast cancer patients who have had a mastectomy and need regional nodal irradiation.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 years, and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 years, and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
complication rate, defined as grade 3 or greater late adverse events and unplanned surgical intervention in patients who undergo mastectomy with reconstruction
Secondary outcome measures
Cosmesis
Disease-free Survival (DFS)
Distant Recurrence Incidence
+7 moreTrial 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
~460
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,696 Total Patients Enrolled
82 Trials studying Breast Cancer
13,824 Patients Enrolled for Breast Cancer
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
Robert W MutterPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
42 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received or will receive extra radiation to my chest wall after mastectomy.My radiotherapy is scheduled within 12 weeks after my last surgery or chemotherapy.I cannot receive radiotherapy due to health reasons.I can take care of myself and am up and about more than half of my waking hours.My breast cancer is at a specific stage and my underarm lymph nodes were checked.I have active systemic lupus or scleroderma.I have been diagnosed with inflammatory breast cancer.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.I am pregnant or not using birth control while being able to conceive.I have had radiation on the same side as my current treatment but not on the opposite side.My breast cancer has come back after treatment.I am 18 years old or older.I had breast cancer surgery and will receive radiation on my chest and nearby lymph nodes.I haven't had any cancer other than breast cancer in the last 5 years.Cancer cells were found at the edge of the tissue removed during my last surgery.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for this research project?
"The clinicaltrials.gov database states that this trial is not looking for any new participants at the moment; it was initially posted in May of 2016 and last updated on November 11th 2022. Nonetheless, there are 1404 other trials currently recruiting patients."
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