[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657807":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":42,"studyPopulation":42,"armGroups":49,"interventions":57,"overallOfficials":42,"centralContacts":68,"locations":74,"responsibleParty":92,"collaborators":42,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":42,"enrollmentInfo":106,"targetDuration":42,"studyType":109,"phases":110,"briefSummary":111,"conditions":112,"keywords":117,"overallStatus":124,"whyStopped":42,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Renaissance Institute of Precision Oncology and Radiosurgery","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of CTCAE v5.0 Grade ≥2 skin adverse events","Proportion of treated patients with at least one Grade ≥2 skin AE within 90 days, graded per protocol by study research nurse practitioner.","90 days after SDRT",[14,18,22,26,30,34,38],{"measure":15,"description":16,"timeFrame":17},"Absence of residual invasive carcinoma on protocol-mandated tissue sampling","Proportion with no residual invasive carcinoma on mandated sampling.","12 months",{"measure":19,"description":20,"timeFrame":21},"Modified RECIST 1.1 response on multiparametric breast MRI","MRI response by modified RECIST 1.1.","Up to 36 months",{"measure":23,"description":24,"timeFrame":25},"PERCIST 1.0 metabolic response on FDG PET\u002FCT","Metabolic response assessed by PERCIST 1.0.","6 and 12 months",{"measure":27,"description":28,"timeFrame":29},"Late Grade ≥2 skin adverse events","Incidence of late Grade ≥2 skin adverse events after treatment.","From 90 days through 36 months",{"measure":31,"description":32,"timeFrame":33},"Rate of salvage surgery","Proportion of participants undergoing salvage surgery.","Through 36 months",{"measure":35,"description":36,"timeFrame":37},"Ipsilateral breast tumor recurrence","Incidence of ipsilateral breast tumor recurrence.","12, 24, and 36 months",{"measure":39,"description":40,"timeFrame":41},"BREAST-Q Breast Conserving Therapy module scores","Change in BREAST-Q Breast Conserving Therapy module scores.","Baseline through 36 months",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"NA","SINGLE_GROUP","TREATMENT",{"masking":48,"maskingDescription":42,"whoMasked":42},"NONE",[50],{"label":51,"type":52,"description":53,"interventionNames":54},"Single-fraction SDRT plus adjuvant endocrine therapy","EXPERIMENTAL","Single-fraction SDRT plus adjuvant endocrine therapy.",[55,56],"Radiation: Stereotactic Radiation Therapy","Drug: Endocrine Therapy",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":42},"RADIATION","Stereotactic Radiation Therapy","Single fraction 24 Gy to PTV with SIB 30 Gy to CTV on Varian Edge with image guidance.",[51],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":42},"DRUG","Endocrine Therapy","Adjuvant aromatase inhibitor or tamoxifen initiated within 30 days of SDRT; on-label; recommended 5 years.",[51],[69],{"name":70,"role":71,"phone":72,"phoneExt":42,"email":73},"Julia Pierson","CONTACT","321-972-1102","jpierson@therenaissanceinstitute.org",[75],{"facility":76,"status":42,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Renaissance Institute for Precision Oncology & Radiosurgery","Winter Park","Florida","32789","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-81.33924,28.6,{"lat":86,"lon":85},[89,90],{"name":70,"role":71,"phone":72,"phoneExt":42,"email":73},{"name":91,"role":71,"phone":42,"phoneExt":42,"email":42},"Evan Thomas, MD, PhD",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Evan Thomas","Principal Investigator","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":107,"type":108},30,"ESTIMATED","INTERVENTIONAL",[44],"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.",[113,114,115,116],"Breast Cancer","Early-Stage Breast Carcinoma","Hormone Receptor-Positive Breast Cancer","HER2-Negative Breast Cancer",[102,118,119,120,121,122,123],"single-fraction SDRT","stereotactic radiosurgery","lumpectomy omission","non-operative","HR-positive","HER2-negative","NOT_YET_RECRUITING","2026-09-21",{"date":127,"type":128},"2026-09-28","ACTUAL",{"date":130,"type":108},"2027-01-01",{"date":132,"type":108},"2032-01-01",{"name":5,"class":6},1]