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Life sciences · Interventional Study
ClinicalTrials.gov · September 28, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07844759). This is a study registration, not published results. Lead sponsor: Renaissance Institute of Precision Oncology and Radiosurgery. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Breast Cancer, Early-Stage Breast Carcinoma, Hormone Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer. Interventions: RADIATION: Stereotactic Radiation Therapy; DRUG: Endocrine Therapy. Primary outcome measures: Incidence of CTCAE v5.0 Grade ≥2 skin adverse events , 90 days after SDRT. Brief summary: SOLIS is a prospective, single-arm, single-institution pilot trial evaluating single-fraction stereotactic radiotherapy (24 Gy to the planning target volume with a simultaneous integrated boost of 30 Gy to the clinical target volume) delivered with a cleared linear accelerator as definitive non-operative local treatment for early-stage, hormone receptor-positive, HER2-negative breast cancer with planned omission of lumpectomy. Adjuvant endocrine therapy is prescribed on-label. The primary endpoint is the incidence of CTCAE v5.0 Grade ≥2 skin adverse events within 90 days of treatment, monitored with a pre-specified Bayesian safety stopping rule. Secondary endpoints include biopsy-confirmed absence of residual invasive carcinoma at 12 months, imaging response on multiparametric MRI and FDG PET/CT, late toxicity, cosmesis, patient-reported outcomes, salvage surgery, and disease control through 36 months.