[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100390163":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":50,"collaborators":31,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":21,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":31,"enrollmentInfo":62,"targetDuration":31,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":35,"whyStopped":31,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University of Miami","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Preoperative SABER","EXPERIMENTAL","* Experimental: Preoperative Stereotactic Ablative Breast Radiotherapy (SABER). Phase I study testing up to 4 dose levels.\n* Non-experimental: Participants will undergo standard partial mastectomy and axillary surgery as per discretion of treating physician 4 to 6 weeks (+ at most 1 week delay) after preoperative SABER is completed.",[13],"Radiation: Stereotactic Ablative Breast Radiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Stereotactic Ablative Breast Radiotherapy","Preoperative SABER: Participants will be treated with an assigned dose level of preoperative SABER, delivered in once a day, 5 fractions given on non-consecutive days, over a period of 2 weeks. In this phase I study, starting with dose level II, a dose level of preoperative SABER will be assigned per study dose-escalation design, treating 2 to 6 patients per dose level. The tested doses are the following:\n\n* Dose Level I: 35 Gy (5 fractions of 7 Gy)\n* Dose Level II (Starting Dose): 40 Gy (5 fractions of 8 Gy)\n* Dose Level III: 45 Gy (5 fractions of 9 Gy)\n* Dose Level IV: 50 Gy (5 fractions of 10 Gy)",[9],[21],"SABER",[23],{"name":24,"affiliation":5,"role":25},"Cristiane Takita, MD, MBA","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Zuzel Rodriguez","CONTACT","305-243-0124",null,"z.rodriguez1@med.miami.edu",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Miami","Florida","33136","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-80.19366,25.77427,{"lat":45,"lon":44},[48,49],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":24,"role":25,"phone":31,"phoneExt":31,"email":31},{"type":25,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Cristiane Takita","Professor of Clinical","100390163","saber-study-for-selected-early-stage-breast-cancer-100390163",false,"NCT04360330","SABER Study for Selected Early Stage Breast Cancer","Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer","Inclusion Criteria:\n\n1. Female, ≥ 50 years of age.\n2. Oncotype or MammaPrint diagnosis results are required prior to the start of treatment\n3. Histologically confirmed invasive breast cancer.\n4. Clinical stage T1N0M0.\n5. Receptor status: Estrogen-Receptor (ER)\u002FProgesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative.\n6. Unifocal breast cancer.\n7. Eastern Cooperative Oncology Group (ECOG) 0, 1.\n8. Ability to undergo MRI.\n9. Women of child-bearing potential (WOCBP) must agree to use adequate contraception or agree to undergo sexual abstinence prior to study entry and for the duration of study participation. WOCBP must have a negative serum or urine pregnancy test at time of enrollment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n10. Ability to understand the investigational nature, potential risks and benefits of the research study and willingness to sign the written informed consent and HIPAA document(s).\n\nExclusion Criteria:\n\n1. Patients without histologically confirmed invasive breast cancer.\n2. Patients without Oncotype or MammaPrint diagnosis results at the start of treatment.\n3. Patients with metastatic disease.\n4. ECOG 2, 3, 4.\n5. Patients that are unable to undergo MRI.\n6. Prior history of radiation to the chest.\n7. History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis).\n8. Any serious medical or psychiatric illness\u002Fcondition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements\u002Ftreatment.\n9. Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer.\n10. Patients unable to consent, who are pregnant or nursing, or are prisoners.","FEMALE","50 Years",{"count":63,"type":64},18,"ESTIMATED","INTERVENTIONAL",[67],"NA","The purpose of this study is to find the most effective dose of radiation therapy to give to breast tumors in a shorter period of time, prior to standard partial mastectomy\u002Faxillary surgery.",[70,71],"Breast Cancer","Early-stage Breast Cancer",[70,71],"2026-07-31",{"date":75,"type":76},"2026-08-03","ACTUAL",{"date":78,"type":76},"2020-08-05",{"date":80,"type":64},"2029-05-31",{"name":5,"class":6},1]