SOLIS: Single-Dose Radiotherapy With Omission of Lumpectomy for Intact Small Breast Cancers

Part of paid clinical trials in Winter Park, Florida.

Sponsor: Renaissance Institute of Precision Oncology and Radiosurgery
Study ID: NCT07844759
Status: Not Yet Recruiting

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Conditions

Breast Cancer
Early-Stage Breast Carcinoma
HER2-Negative Breast Cancer
Hormone Receptor-Positive Breast Cancer

Eligibility Criteria

Sex: ALL
Age: 50 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Stereotactic Radiation Therapy — RADIATION
Single fraction 24 Gy to PTV with SIB 30 Gy to CTV on Varian Edge with image guidance.
Endocrine Therapy — DRUG
Adjuvant aromatase inhibitor or tamoxifen initiated within 30 days of SDRT; on-label; recommended 5 years.

Study Details

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.