[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Renaissance Institute of Precision Oncology and Radiosurgery\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100657807","solis-single-dose-radiotherapy-with-omission-of-lumpectomy-for-intact-small-breast-cancers-100657807",false,"NCT07844759","SOLIS: Single-Dose Radiotherapy With Omission of Lumpectomy for Intact Small Breast Cancers","Single-Dose Stereotactic Radiosurgery (SDRT) as Definitive Non-Operative Treatment for Early-Stage Breast Cancer: A Prospective Single-Arm Pilot Trial With Bayesian Safety Monitoring (SOLIS \u002F Protocol RAD 2024)","SOLIS","Inclusion Criteria:\n\n* Invasive ductal carcinoma or favorable special histology confirmed by core biopsy.\n* Unifocal tumor ≤2 cm; estrogen receptor-positive and HER2-negative; grade 1-2; clinically node-negative (cN0).\n* Age ≥65, or age 50-64 when surgery is unsuitable or declined (capped at 10 of 30 participants).\n* Tumor ≥5 mm from skin and pectoralis; willing to receive adjuvant endocrine therapy.\n* Zubrod performance status 0-2; able to undergo MRI and FDG PET\u002FCT; informed consent.\n\nExclusion Criteria:\n\n* Multifocal or multicentric disease; pure DCIS; invasive lobular carcinoma \\>10%; extensive intraductal component or diffuse calcifications.\n* Grade 3, triple-negative, or HER2-positive disease; nodal or distant metastases.\n* Prior ipsilateral breast radiation or excisional biopsy\u002Flumpectomy; neoadjuvant chemotherapy.\n* Tumor \\\u003C5 mm from skin or pectoralis; inability to meet dose constraints or PTV \\>60 cm³.\n* Connective tissue disease; prohibited other malignancy; pregnancy or lactation.\n* Pathogenic BRCA1, BRCA2, PALB2, or TP53 variant; investigator judgment that participation is inappropriate.","ALL","50 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","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\u002FCT, late toxicity, cosmesis, patient-reported outcomes, salvage surgery, and disease control through 36 months.",[27,28,29,30],"Breast Cancer","Early-Stage Breast Carcinoma","Hormone Receptor-Positive Breast Cancer","HER2-Negative Breast Cancer",[15,32,33,34,35,36,37],"single-fraction SDRT","stereotactic radiosurgery","lumpectomy omission","non-operative","HR-positive","HER2-negative","NOT_YET_RECRUITING","2026-09-21",{"date":41,"type":42},"2026-09-28","ACTUAL",{"date":44,"type":21},"2027-01-01",{"date":46,"type":21},"2032-01-01",{"name":48,"class":49},"Renaissance Institute of Precision Oncology and Radiosurgery","OTHER",""]