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)

Banner MD Anderson Northern Colorado

Loveland, Colorado, United States

Cooper Hospital University Medical Center

Voorhees Township, New Jersey, United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07076485


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