[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449393":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":72,"centralContacts":77,"locations":87,"responsibleParty":105,"collaborators":10,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":10,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":121,"studyType":122,"phases":10,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":128,"whyStopped":10,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"National Institute of Oncology, Hungary","OTHER",[8,16,25,30],{"label":9,"type":10,"description":11,"interventionNames":12},"LuminalA",null,"1. tamoxifen (+ LHRH analogue for premenopausal participant)\n2. non-steroidal aromatase inhibitor (+ LHRH analogue for premenopausal participant)\n3. Non-steroidal aromatase inhibitor in non-resectable tumor (+ LHRH analogue in premenopausal participant) + CDK4 \u002F 6 inhibitor",[13,14,15],"Drug: Tamoxifen","Drug: Goserelin","Drug: Letrozole 2.5Mg Tab",{"label":17,"type":10,"description":18,"interventionNames":19},"LuminalB (Her2 negative)","1. 12 times weekly paclitaxel (80 mg \u002F m˄2) followed by 4 times every 3 weeks epirubicin (E) (90-100 mg \u002F m˄2) + cyclophosphamide (C) (600) (preferred)\n2. 4x 3 weekly E (90-100mg \u002F m˄2) + C (600mg \u002F m˄2), then\n\n   1. docetaxel (90-100 mg \u002F m˄2) 4 times in every 3 weeks or\n   2. 12x weekly paclitaxel (80mg \u002F m˄2)\n3. 4x every 2 weeks Epirubicin (E) (90-100mg \u002F m˄2) + Cyclophosphamid (C) (600mg \u002F m˄2), then\n\n   1. 4 times every 2 weeks with paclitaxel (175 mg \u002F m˄2) or\n   2. 12x weekly paclitaxel (80mg \u002F m˄2)\n4. TC: docetaxel (75 mg \u002F m˄2) + cyclophosphamide (600 mg \u002F m˄2) every 21 days with GCSF prevention (6 cycles)",[13,14,15,20,21,22,23,24],"Drug: Epirubicin","Drug: cyclophosphamide","Drug: Docetaxel","Drug: paclitaxel","Drug: trastuzumab",{"label":26,"type":10,"description":27,"interventionNames":28},"Her2 positive","1. 4x 3 weeks E (90-100mg \u002F m˄2) + C (600mg \u002F m˄2), then\n\n   1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +\u002F- pertuzumab (3 weekly) or\n   2. 4x 3 weekly docetaxel (100mg \u002F m˄2) + trastuzumab +\u002F- pertuzumab\n2. Docetaxel (75 mg \u002F m˄2) + carboplatin (AUC6) + trastuzumab +\u002F- pertuzumab 6 times every 3 weeks c) E (90-100mg \u002F m˄2) + C (600mg \u002F m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +\u002F- pertuzumab (3 weekly)",[13,14,15,20,21,22,23,24,29],"Drug: pertuzumab",{"label":31,"type":10,"description":32,"interventionNames":33},"Triple-negative breast cancer","1. Paclitaxel (80 mg \u002F m˄2) +\u002F- carboplatin (AUC2) 12 times weekly, then E (90-100 mg \u002F m˄2) + C (600 mg \u002F m˄2) 4 times three weekly (preferred)\n2. 4x every 3 weeks E (90-100mg \u002F m˄2) + C (600mg \u002F m˄2), then\n\n   1. 4x docetaxel (90-100mg \u002F m˄2) or\n   2. 12x weekly paclitaxel (80mg \u002F m˄2) +\u002F- carboplatin (AUC2 )\n3. 4x every 2 weeks E (90-100mg \u002F m˄2) + C (600mg \u002F m˄2), then\n\n   1. 4 times every 2 weeks paclitaxel (175 mg \u002F m˄2) or\n   2. 12x weekly paclitaxel (80mg \u002F m˄2) +\u002F- carboplatin (AUC2)",[20,21,22,23,34],"Drug: Capecitabine",[36,41,44,49,53,56,59,62,66,69],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"DRUG","Tamoxifen","endocrine therapy",[26,9,17],{"type":37,"name":42,"description":39,"armGroupLabels":43,"otherNames":10},"Goserelin",[26,9,17],{"type":37,"name":45,"description":39,"armGroupLabels":46,"otherNames":47},"Letrozole 2.5Mg Tab",[26,9,17],[48],"letrozole",{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"Epirubicin","chemotherapy",[26,17,31],{"type":37,"name":54,"description":51,"armGroupLabels":55,"otherNames":10},"cyclophosphamide",[26,17,31],{"type":37,"name":57,"description":51,"armGroupLabels":58,"otherNames":10},"Docetaxel",[26,17,31],{"type":37,"name":60,"description":51,"armGroupLabels":61,"otherNames":10},"paclitaxel",[26,17,31],{"type":37,"name":63,"description":64,"armGroupLabels":65,"otherNames":10},"trastuzumab","biological treatment",[26,17],{"type":37,"name":67,"description":64,"armGroupLabels":68,"otherNames":10},"pertuzumab",[26],{"type":37,"name":70,"description":51,"armGroupLabels":71,"otherNames":10},"Capecitabine",[31],[73],{"name":74,"affiliation":75,"role":76},"Gabor Rubovszky","NIO Hungary","PRINCIPAL_INVESTIGATOR",[78,84],{"name":79,"role":80,"phone":81,"phoneExt":82,"email":83},"gabor Rubovszky","CONTACT","+3612248600","3442","garub@oncol.hu",{"name":85,"role":80,"phone":81,"phoneExt":10,"email":86},"Balazs Madaras","madarasb@oncol.hu",[88],{"facility":89,"status":10,"city":90,"state":10,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"National Institute of Oncolgy","Budapest","1122","Hungary","HU",{"type":95,"coordinates":96},"Point",[97,98],19.04045,47.49835,{"lat":98,"lon":97},[101,103],{"name":102,"role":80,"phone":81,"phoneExt":82,"email":83},"Gabor Rubovszky, Ph D",{"name":85,"role":80,"phone":81,"phoneExt":10,"email":104},"madarasb@gmail.com",{"type":76,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Dr. Zoltan Matrai","Head of Surgical Oncology","100449393","neoadjuvant-treatment-of-breast-cancer-100449393",false,"NCT05131893","Neoadjuvant Treatment of Breast Cancer","Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial","Inclusion Criteria:\n\n1. Participant over 18 years of age .\n2. Histologically confirmed (core biopsy) invasive breast tumor.\n3. Tumor extent for the indication:\n\n   * regression must be achieved for radical surgical removal or\n   * regression is required for breast-conserving surgery or\n   * if hormone receptor (HR)-positive and Her2-: stage IIB (cT2N1 or cT3NO) - IIIC,\n   * if HR-negative: stage IIA (cT2N0 or cT0-1N1) - IIIC Note: In the case of a locally advanced, irresectable case, if the possibility of radical surgery later is a realistic goal, the participant may be included in the study.\n4. Appropriate general condition: ECOG 0-1\n5. Proper organ function\n\n   * Neutrophil count ≥ 1.5 G \u002F l, platelet count ≥ 100 G \u002F l, hemoglobin ≥ 10 g \u002F dl\n   * Alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST) is less than 1.5 times the upper limit of the normal range\n   * bilirubin less than 1.5 times the upper limit of the normal range (except Gilbert's disease, where less than 3 times)\n   * creatinine less than 1.5 times the upper limit of the normal range or estimated glomerular filtration rate (eGFR) higher than 60 ml \u002F min\n\nExclusion Criteria:\n\n1. Proven or suspected distant metastasis.\n2. No staging studies have been performed: at least chest x-ray, abdominal ultrasound. It is preferred to perform CT from the chest, abdomen, pelvic regions and bone isotope, or PET \u002F CT if possible in case of lymph node involvement.\n3. Known significant heart disease: major arrhythmia or significant conduction defect (grade 2 or more), infarction or unstable angina within 6 months, cardiac collapse without appropriate therapy, long QT syndrome, heart failure (≥New York Heart Association\u002FNYHA II)\n4. Other severe acute or chronic conditions (organic or psychiatric illness, laboratory abnormality) that, in the opinion of the treating physician, result in an unacceptable increase in the risk of chemotherapy and are contraindicated in routine clinical practice.\n5. Pregnancy or if the participant does not agree to use an appropriate non-hormonal method of contraception.","ALL","18 Years","100 Years",{"count":119,"type":120},300,"ESTIMATED","10 Years","OBSERVATIONAL","Observational investigation of participants who are given neoadjuvant treatment for invasive breast cancer. The scope of the study is to collect information on standardized treatment results, to explore the causes of dose modification and its effect on efficacy, to explore potential prognostic factors, and to explore the long-term side effects of different treatment modalities.",[125],"Breast Cancer",[127],"Neoadjuvant systemic therapy","NOT_YET_RECRUITING","2021-11-20",{"date":131,"type":132},"2021-11-23","ACTUAL",{"date":134,"type":120},"2022-03",{"date":136,"type":120},"2031-12",{"name":5,"class":6},1]