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
NCT07076485 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 768
Last updated 2026-05-20
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.
Conditions
Interventions
- RADIATION
-
Ultrahypofractionated Radiation
Given by infusion
- RADIATION
-
Moderately Hypofractionated Radiation
Given by infusion
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Benjamin Smith, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-19
- Primary Completion
- 2029-01-01
- Completion
- 2031-01-01
Countries
- United States
Study Locations
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