Ultrahypofractionation and Normal Tissue Toxicity
This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer. The names of the two study groups in this research study are: * Proton Radiation Therapy (PBT) * Conventional or "Photon" Radiation Therapy (XRT)
Conditions:
🦠 Breast Cancer 🦠 Breast Cancer Female 🦠 Breast Cancer Stage II 🦠 Breast Cancer Stage III 🦠 Myocardial Fibrosis
🗓️ Study Start (Actual) 15 August 2023
🗓️ Primary Completion (Estimated) 17 September 2025
✅ Study Completion (Estimated) 17 September 2025
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * ≥18 years of age
    • * 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:

    • * Person who is pregnant or breastfeeding.
    • * 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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 June 2023
  • First Submitted that Met QC Criteria 12 June 2023
  • First Posted 22 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 January 2024
  • Last Update Posted 12 January 2024
  • Last Verified January 2024