Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
768
Participants Needed
3
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive breast cancer
- Recommended for regional nodal irradiation by a radiation oncologist
- Negative final surgical margins
- No more than 12 weeks since final breast/lymph node surgery or chemotherapy
- Age 18 years or older
- Prior or concurrent malignancy allowed if it does not interfere with study assessments
- Ability and willingness to provide informed consent
- May be enrolled in other non-conflicting studies
- For low-risk lumpectomy cohort: pathologic or clinical stage appropriate, treated with lumpectomy or axillary surgery only, no nodal boost recommended
- For high-risk lumpectomy cohort: treated with neoadjuvant chemotherapy, clinical stage cT0-T4b N1-N3a/b/c, treated with lumpectomy or axillary surgery only, nodal boost recommended
- For low-risk mastectomy cohort: pathologic or clinical stage appropriate, residual tumor cellularity ≤ 20% if neoadjuvant chemotherapy, treated with mastectomy, surgical margins ≥ 2 mm, no or focal lymphovascular invasion, age 40 years or older, no chest wall boost recommended
- For high-risk mastectomy cohort: appropriate pathologic or clinical stage, treated with mastectomy, chest wall and/or nodal boost recommended
- Women of child-bearing potential and men must agree to use adequate contraception during radiation treatment
- Women not required to have pregnancy test at enrollment but must comply with pregnancy assessment policy
You will not qualify if you...
- Prior therapeutic radiation overlapping the breast or nodal areas needing radiation
- History of scleroderma
- Pregnant women
- Psychiatric illness or social situations limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Cooper Hospital University Medical Center
Voorhees Township, New Jersey, United States, 08103
Actively Recruiting
2
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
B
Benjamin Smith, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
8
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