NCT07076485

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 768 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: To compare the occurrence of any grade 2 or higher NCI CTCAE toxicity from start of RNI through 18 months follow up by treatment arm for each of the four randomized cohorts (low-risk lumpectomy, low-risk mastectomy, high-risk lumpectomy, high-risk mastectomy). Secondary Objectives: To compare treatment toxicity, local-regional control, disease-free survival, and overall survival by treatment arm for each of the four randomized cohorts. To compare patient-reported outcomes including cosmetic satisfaction, physical wellbeing, lymphatic function, and financial toxicity by treatment arm for each of the four randomized cohorts. To compare photographic outcome of the treated breast or reconstructed breast by treatment arm for each of the four randomized cohorts. To evaluate and compare radiation treatment plans by treatment arm for each of the four randomized cohorts, including target coverage, dose to organs at risk, dose homogeneity, and low-dose scatter. To compare biometric data before, during, and after radiation collected by patients' personal Apple Watches.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Ultrahypofractionated Radiation	Given by infusion
RADIATION	Moderately Hypofractionated Radiation	Given by infusion

Timeline

• Start date: 2025-08-19
• Primary completion: 2029-01-01
• Completion: 2031-01-01
• First posted: 2025-07-22
• Last updated: 2026-04-15

Locations

3 sites across 1 country: United States