RecruitingBreast Cancer
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
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: M.D. Anderson Cancer Center
You may qualify if…
- ✓ Eligibility Criteria Applicable to All Cohorts
- ✓ Histologically confirmed invasive breast cancer (nodal involvement from presumed invasive breast cancer in the setting of occult breast cancer is sufficient to meet this criteria)
- ✓ 1\. Regional nodal irradiation recommended by treating radiation oncologist. 2 Negative final surgical margins. 3 No more than 12 weeks have elapsed since final breast/lymph node surgery for patients treated with surgery alone or neoadjuvant chemotherapy. No more than 12 weeks have elapsed since final cytotoxic chemotherapy for patients who received adjuvant chemotherapy. 5. Age ≥18 years. Because breast cancer is exceedingly rare in patients \< 18 years of age, children are excluded from this study. 6. Patients with a prior or concurrent malignancy are eligible provided that the natural history and treatment of the prior or concurrent malignancy does not interfere with the safety or efficacy assessment of the investigational radiation regimen used in this trial. 7. Ability to understand and the willingness to sign a written informed consent document. 8. Concurrent enrollment on other observational, translational, or therapeutic studies is allowed provided there is no direct conflict between the other protocol and the radiation regimen proscribed in this trial.
- ✓ Eligibility Criteria for the Low-Risk Lumpectomy Cohort
- ✓ 1. For patients treated with upfront surgery, pathologic stage pT0-T4b N0-N3a breast cancer without infraclavicular or internal mammary nodal involvement.
- ✓ 2. For patients treated with neoadjuvant chemotherapy, clinical stage cT0-T4b N0-N2a breast cancer.
- ✓ 3. Treated with lumpectomy (or axillary surgery only in the case of occult primary breast cancer)
- ✓ 4. No nodal boost recommended by the treating radiation oncologist.
You may not qualify if…
- ✕ History of therapeutic radiation overlapping with the index breast or nodal basins that require radiation therapy.
- ✕ History of scleroderma
- ✕ Pregnant women are excluded from this study because ionizing radiation has the potential for teratogenic or abortifacient effects.
- ✕ Patients with psychiatric illness/social situations that would limit compliance with study requirements
Where it's recruiting
Source: ClinicalTrials.gov · NCT07076485 · last updated 2026-09-02