Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2023-08-15
2026-12-31
Brief Summary
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The names of the two study groups in this research study are:
* Proton Radiation Therapy (PBT)
* Conventional or "Photon" Radiation Therapy (XRT)
Detailed Description
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Participants will be randomized into one of two study groups: proton beam radiation therapy versus photon radiation therapy. Randomization means that participants are put into a group by chance.
Study procedures includes screening for eligibility, study treatment visits, Cardiac Magnetic Resonance Imaging (MRI), blood tests, and questionnaires.
The National Cancer Institute, American Society of Clinical Oncology, and Claflin Grant are supporting this research by providing funding for the research study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Accelerated Proton Beam Radiation Therapy (PBT) Group
Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:
* Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.
* Radiation therapy 1x daily for 5 days over 1 week.
* End of radiation therapy visit with blood tests.
* 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.
* 12 month follow up visit with questionnaires and photographic imaging.
Accelerated Proton Beam Radiation Therapy (PBT)
per protocol
Accelerated Photon Radiation Therapy (XRT) Group
Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:
* Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.
* Radiation therapy 1x daily for 5 days over 1 week.
* End of radiation therapy visit with blood tests.
* 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.
* 12 month follow up visit with questionnaires and photographic imaging.
Accelerated Photon Radiation Therapy (XRT)
per protocol
Interventions
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Accelerated Proton Beam Radiation Therapy (PBT)
per protocol
Accelerated Photon Radiation Therapy (XRT)
per protocol
Eligibility Criteria
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Inclusion Criteria
* Non-metastatic Breast Cancer patients who are scheduled to receive conventional left-sided or bilateral breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
* Prior chemotherapy is permitted
* Ability to understand and the willingness to sign a written informed consent document
* No contraindication to MRI
* Patients with right-sided breast cancer or patients with left-sided patients not requiring treatment to the IMNs, but where cardiac anatomy is determined to be unfavorable by the study PI, will be considered eligible.
Exclusion Criteria
* Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity. No cytotoxic therapy or radiotherapy may be used during radiation therapy.
* Contra-indication to gadolinium contrast (e.g., chronic kidney disease)
* Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
American Society of Clinical Oncology
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Rachel Beth Jimenez
Principal Investigator
Principal Investigators
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Rachel Jimenez, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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23-182
Identifier Type: -
Identifier Source: org_study_id