[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416099":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":63,"collaborators":12,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":12,"enrollmentInfo":75,"targetDuration":12,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":48,"whyStopped":12,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Instituto do Cancer do Estado de São Paulo","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Systemic therapy","NO_INTERVENTION","Patients will receive standard of care with systemic therapy alone.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Local therapy + systemic therapy","EXPERIMENTAL","In addition to systemic therapy, patients will receive local therapy for all oligometastatic sites. Options of local therapy will be radiotherapy, radiofrequency ablation, and\u002F or surgery.",[18,19,20],"Radiation: Radiotherapy","Procedure: Surgery","Other: Radiofrequency ablation",[22,27,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":12},"RADIATION","Radiotherapy","Radiation therapy for oligometastatic sites",[14],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":12},"PROCEDURE","Surgery","Surgery for oligometastatic sites",[14],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":12},"Radiofrequency ablation","Radiofrequency ablation for oligometastatic sites",[14],[37],{"name":38,"affiliation":5,"role":39},"Renata C. Bonadio, MD","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":12,"email":44},"CONTACT","+5511989554040","rrccbonadio@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"ICESP","RECRUITING","São Paulo","01246-000","Brazil","BR",{"type":54,"coordinates":55},"Point",[56,57],-46.63611,-23.5475,{"lat":57,"lon":56},[60],{"name":61,"role":42,"phone":62,"phoneExt":12,"email":44},"Renata Bonadio, MD","+551138932000",{"type":64,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100416099","phase-2-local-therapy-for-erpr-positive-oligometastatic-breast-cancer-100416099",false,"NCT04698252","Local Therapy for ER\u002FPR-positive Oligometastatic Breast Cancer","Local Therapy for Hormone Receptor-positive Oligometastatic Breast Cancer - a Phase II Randomized Trial","LARA","Inclusion Criteria:\n\n* Female sex\n* ≥ 18 years of age\n* Histologically confirmed invasive breast cancer, with oligometastatic disease defined as one of the following criteria: 1) One to four bone lesions; 2) One to four lung and\u002F or hepatic lesions; 3) Distant metastasis limited to ipsilateral cervical lymph nodes; 4) Distant metastasis limited to contralateral axillary lymph nodes\n* Oligometastatic sites amenable to treatment with a local therapy modality, including surgical resection, stereotactic radiotherapy, or radiofrequency ablation\n* Estrogen receptor-positive and\u002F or progesterone receptor-positive breast cancer\n* Partial response or stable disease after at least six months of systemic therapy for breast cancer\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Measurable or non-measuble disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Life expectancy of at least 12 weeks\n* For women in childbearing age, negative pregnancy test until 21 days before the date of study enrollment.\n* Signed informed consent form\n* Disposition and aptitude to fulfill the study protocol during the study duration\n\nExclusion Criteria:\n\n* HER2-positive breast cancer\n* Progressive disease during the last systemic treatment received for metastatic disease\n* Previous local therapy for distant metastasis\n* Current or previous history of severe diseases, such as clinically relevant heart failure, acute myocardium infarction in the last six months, chronic obstructive lung disease, HIV infection, chronic active hepatitis B or C infection, current serious uncontrolled infections or other severe diseases that may impact patients' expected survival)\n* Current or previous history of other invasive malignancy within the last five years, excluding non-melanoma skin cancer","FEMALE","18 Years",{"count":76,"type":77},74,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","Randomized phase 2 trial to evaluate the efficacy of local therapy for oligometastasis from ER\u002FPR-positive breast cancer. The study hypothesis is that local therapy in addition to systemic therapy improves progression-free survival in comparison with systemic therapy alone.",[83],"Breast Cancer",[85,86,29,24,33],"Oligometastasis","Hormone Receptor Positive","2022-08-05",{"date":89,"type":90},"2022-08-08","ACTUAL",{"date":92,"type":90},"2021-04-01",{"date":94,"type":77},"2031-04-01",{"name":5,"class":6},1]