[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444720":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":63,"collaborators":42,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":42,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":42,"enrollmentInfo":74,"targetDuration":42,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":49,"whyStopped":42,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Rome Tor Vergata","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"40Gy\u002F5fx","EXPERIMENTAL","The starting dose level will be 8Gy x 5 fractions, i.e., 40 Gy\u002F5 nonconsecutive once-daily fractions.",[13],"Radiation: Stereotactic Body Radiation Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"42.5Gy\u002F5fx","The intermediate dose level will be 8.5Gy x 5 fractions, i.e. 42.5Gy\u002F5 nonconsecutive once-daily fractions.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"45Gy\u002F5fx","The higher dose level will be 9Gy x 5 fractions, i.e. 45Gy\u002F5 nonconsecutive once-daily fractions",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","Stereotactic Body Radiation Therapy","In every group, the dose is prescribed at the edge of the PTV. To be approved, 95% of the PTV will be conformally covered by the prescription isodose surface and 99% of PTV will receive a minimum of 90% of the prescription dose.",[9,15,19],[29,30,31],"SBRT","Stereotaxis","Stereotactic Radiotherapy",[33],{"name":34,"affiliation":35,"role":36},"Rolando Maria D'Angelillo","Fondazione Policlinico Tor Vergata","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Laura Cedrone","CONTACT","+393669879224",null,"radioterapia@ptvonline.it",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":43},"Cecilia Sciommari","+390620908372",[48],{"facility":35,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Rome","00133","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],12.51133,41.89193,{"lat":58,"lon":57},[61,62],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},{"name":45,"role":40,"phone":46,"phoneExt":42,"email":43},{"type":36,"investigatorFullName":39,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Resident","100444720","sbrt-in-early-breast-cancer-in-elderly-women-100444720",false,"NCT05071105","SBRT in Early Breast Cancer in Elderly Women","Stereotactic Ablative Body Radiotherapy in Elderly Women With Early Breast Cancer Unsuitable for Surgery and Elected to Receive Primary Endocrine Therapy Alone","Inclusion Criteria:\n\n* Age ≥ 75 years\n* Histologically confirmed diagnosis of local disease only (cT1-T2 N0 M0)\n* Luminal like A or B (estrogen receptor positive and\u002For progesterone receptor positive and Her2 negative Tumors)\n* SBRT within 2 months after hormonal therapy start\n\nExclusion Criteria:\n\n* Metastatic Disease\n* Evidence of loco-regional nodal disease\n* Multifocal or multicentric tumors\n* Prior radiotherapy to the region of the study cancer that would result in overlap of therapy fields\n* Concurrent systemic disorders that contraindicate radiotherapy","FEMALE","75 Years",{"count":75,"type":76},30,"ESTIMATED","INTERVENTIONAL",[79],"NA","Surgical treatment represents the standard of local therapy in patients with early breast cancer, however in women over75, the comorbidities related to aging reduce the possibility of candidates for surgical treatment. In the United Kingdom it is estimated that over 40% of elderly women do not receive surgery for their breast cancer, and that their primary treatment is hormonal only, the so-called primary endocrinotherapy.\n\nIn Italy the recent AIOM guidelines of 2019 exclude, in patients with hormone-sensitive disease and age older than 70, the omission of surgery in favor of hormone therapy alone, thus underlining the importance of a treatment local. However, there are currently no local treatments that could in any way effectively control the primary tumor.\n\nIn recent years, SRT has widely found space as a therapeutic alternative in patients not fit for surgery.\n\nStereotactic Radiotherapy is a non-invasive treatment with ablative intent obtained with highly focused high intensity fields for a few fractions (generally 1-5). It is the standard treatment for surgically inoperable lung cancers, and is also used in the treatment of liver metastases, intermediate-risk prostate cancer and locally advanced pancreatic cancers. The applications of stereotactic treatment in breast cancer are limited to the neoadjuvant and adjuvant setting.\n\nAgainst this backgroung, in elderly patients with localized breast cancer candidates for hormonal therapy and non-fit for surgery due to age or comorbidity, a SBRT could more effectively control local disease, not excluding local treatment rather than in itself it is considered very important.",[82],"Breast Neoplasm Female",[84],"Radiotherapy","2025-05-25",{"date":87,"type":88},"2025-05-30","ACTUAL",{"date":90,"type":88},"2021-01-01",{"date":92,"type":76},"2026-12-31",{"name":5,"class":6},1]