RecruitingPhase 2NCT07076485
Shortening Adjuvant Photon and Proton Irradiation (SAPPHIRe-II): A 4 Cohort, Randomized, Phase II Multi-center Trial Evaluating Shorter Schedules of Adjuvant Regional Nodal Irradiation Among Women and Men With Node-positive and High-risk Node-negative Invasive Breast Cancer
Sponsor
M.D. Anderson Cancer Center
Enrollment
768 participants
Start Date
Aug 19, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
To learn about the effects of shorter RNI regimens in patients with breast cance who have had a lumpectomy or mastectomy and who are at higher risk for lower risk for the disease returning.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study (SAPPHIRe-II) is testing whether shorter courses of radiation therapy to the lymph nodes work just as well as standard-length courses for women and men with breast cancer that has spread to the lymph nodes or has high-risk features.
**You may be eligible if...**
- You have been diagnosed with invasive breast cancer confirmed by biopsy
- Your surgeon and radiation oncologist have recommended radiation to the regional lymph nodes
- Your surgical margins are clear (no cancer at the edges)
- No more than 12 weeks have passed since your last surgery or chemotherapy
- You are 18 years or older
**You may NOT be eligible if...**
- You have active cancer in both breasts at the time of diagnosis (bilateral breast cancer may have specific criteria)
- Your surgical margins are not clear
- More than 12 weeks have passed since your last treatment
- You are under 18 years old
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
RADIATIONUltrahypofractionated Radiation
Given by infusion
RADIATIONModerately Hypofractionated Radiation
Given by infusion
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07076485
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