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A Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation

A Randomized Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation

NCT02783690•Mayo Clinic

View on ClinicalTrials.gov

Summary

This is a randomized controlled trial to determine the safety of 15 fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients requiring regional nodal irradiation. Proton therapy is recognized as a standard option for the delivery of radiotherapy for breast cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years
•Histologic confirmation of breast cancer resected by mastectomy with or without immediate reconstruction and chest wall and regional nodal irradiation planned.
•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
•ECOG Performance Status (PS) 0 to 2. (Appendix I).
•Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
•Radiotherapy must begin within 12 weeks of last surgery (breast or axilla) or last chemotherapy.
•Note: Breast implants and expanders allowed
•Able to and provides IRB approved study specific written informed consent
•Ability to complete questionnaire (s) by themselves or with assistance
•Able to complete all mandatory tests listed in section 4.0
+4 more criteria

Exclusion Criteria

•Medical contraindication to receipt of radiotherapy.
•Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent.
•Active systemic lupus or scleroderma.
•Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
•Prior receipt of ipsilateral breast or chest wall radiation that would result in significant overlap of radiation therapy fields. Prior contralateral radiotherapy for breast cancer is allowed.
•Positive margins after definitive surgery
•History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entry
•Inflammatory breast cancer
•Recurrent Breast Cancer
+1 more criteria

Locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

May 18, 2016

Primary Completion Date

October 21, 2020

Completion Date

November 18, 2023

Last Updated

December 4, 2025

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Hypofractionation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of 15 Fraction vs 25 Fraction Pencil Beam Scanning Proton Radiotherapy After Mastectomy in Patients Requiring Regional Nodal Irradiation

Inclusion Criteria

Exclusion Criteria

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