[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641245":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":51,"collaborators":30,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":30,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":75,"whyStopped":30,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Virginia Commonwealth University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Partial Breast Irradiation","EXPERIMENTAL","Brachytherapy delivered with multiple interstitial catheters, given in a single fraction over 1 day",[13],"Drug: Partial Breast Irradiation",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day",[9],[20],"Brachytherapy",[22],{"name":23,"affiliation":5,"role":24},"Bridget Quinn, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Massey IIT Research Operations","CONTACT","804-628-6430",null,"masseyepd@vcu.edu",[33],{"facility":5,"status":30,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Richmond","Virginia","23298","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-77.46026,37.55376,{"lat":43,"lon":42},[46,50],{"name":47,"role":28,"phone":48,"phoneExt":30,"email":49},"Massey CTO Breast Team","804-828-5406","masseyctbrst@vcu.edu",{"name":23,"role":24,"phone":30,"phoneExt":30,"email":30},{"type":52,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100641245","phase-2-single-fraction-interstitial-breast-brachytherapy-100641245",false,"NCT07654257","Single FrAction Interstitial BreaSt BracHytherApy","Single FrAction Interstitial BreaSt BracHytherApy (SASHA)","SASHA","Inclusion Criteria:\n\n* Female\n* New diagnosis of Ductal Carcinoma in Situ (DCIS) and\u002For invasive breast carcinoma per histologic evaluation\n* Age 40-85 at diagnosis\n* Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist\n* T stage of Tis, T1, or T2\n* T2 tumors must be ≤3 cm in maximum diameter\n* If the tumor is human epidermal growth factor receptor (HER2)-positive, the patient is planning to receive or has already received HER2-directed therapy\n* For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \\[with a minimum of 6 axillary nodes removed\\]) and the axillary node(s) must be pathologically negative Note: N0(i+) is not an exclusion criterion\n\nNote: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:\n\n* ≥70 years of age\n* Estrogen receptor (ER)+, progesterone receptor (PR)+\u002F-, HER2-\n* Grade 1-2 breast cancer\n* Tumor ≤2 cm in size\n\nNote: If patients meet all the following criteria, the decision to avoid sentinel lymph node biopsy can be at the discretion of the breast surgeon:\n\n* 50-69 years of age\n* Grade 1-2 breast cancer\n* Clinically negative axilla by ultrasound and\u002For magnetic resonance imaging (MRI)\n* ER+, PR+, HER2-\n* Tumor ≤2 cm in size\n* Agrees to comply with aromatase inhibitor recommendation\n* Ability to begin brachytherapy within 12 weeks following lumpectomy, re- excision of margins, or completion of chemotherapy\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Active collagen-vascular disease\n* Paget's disease of the breast\n* Any prior history of DCIS or invasive breast cancer prior to the current diagnosis\n* Any prior history of breast radiation therapy (RT) or thoracic RT for any condition\n* Multicentric carcinoma (DCIS or invasive)\n* Synchronous bilateral invasive or non-invasive breast cancer\n* Surgical margins that cannot be microscopically assessed or that are positive\n* Treatment with neoadjuvant chemotherapy\n* Excision cavity that cannot be clearly delineated or is not amenable to implant per the treating investigator\n* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements","FEMALE","40 Years","85 Years",{"count":65,"type":66},134,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This phase 2, single arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.",[72],"Breast Cancer",[72,74],"Radiation","NOT_YET_RECRUITING","2026-06-16",{"date":78,"type":79},"2026-06-18","ACTUAL",{"date":81,"type":66},"2026-09-01",{"date":83,"type":66},"2036-09-30",{"name":5,"class":6},1]