[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"xuexin he\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100374698","radical-local-vs-palliative-therapy-for-breast-cancer-patientts-with-ipsilateral-humerus-or-sternum-oligometastasis-100374698",false,"NCT04158843","Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis","A Randomized, Open Label Trial to Evaluate Radical Local Treatment Versus Palliative Treatment for Breast Cancer Patients With Ipsilateral Humerus or Sternum Oligometastasis","BOMB","Inclusion Criteria:\n\n* Patients provided written informed consent\n* Women aged 18-75 years old\n* Histologically confirmed breast cancer and after radical mastectomy\n* Patients of breast cancer with ipsilateral humerus or sternum oligometastasis, and there is no imaging evidence of other site metastases\n* Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade = 1 from any acute CTCAE v. 5.0 grade =2 side effects of previous treatments\n* Without infection of human immunodeficiency virus (HIV) on central laboratory assay results prior to randomization\n* Alanine aminotransferase (ALT) \\\u003C\u002F= 2.5 × the upper limit of normal (ULN), Aspartate aminotransferase (AST) \\\u003C\u002F= 2.5 × ULN prior to randomization\n* Total bilirubin (TBIL) \\\u003C\u002F= 1.25 × ULN\n* Alkaline phosphatase (ALK) \\\u003C\u002F= 2.5 × ULN\n* Gamma glutamyl transpeptidase (GGT) \\\u003C\u002F= 2.5 × ULN\n* Albumin \\>\u002F= 30g\u002FL\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2\n* Women of child-bearing age should take effective contraceptive measures\n* Serum total bilirubin (TBil) \\\u003C\u002F= 1.5 × ULN\n* Serum creatinine (Scr) \\\u003C\u002F= 1.5 × ULN\n* White blood cell count (WBC) \\>\u002F= 3×109\u002FL, Blood neutrophil count \\>\u002F= 1.5×109\u002FL, Platelet count \\>\u002F= 100×109\u002FL, Hemoglobin (HB) \\>\u002F= 9 g\u002FdL\n\nExclusion Criteria:\n\n* Without radical mastectomy of the primary breast lesions\n* No radical resection or radiotherapy is possible for metastatic lesions\n* Other site metastases except ipsilateral humerus or sternum are present\n* With multiple metastatic lesions\n* Any other current malignancy or malignancy diagnosed within the past five years (other than carcinoma in situ or stage Ia carcinoma of the cervix, skin basal cell carcinoma and papillary thyroid carcinoma at early stage)\n* Active infection with human immunodeficiency virus (HIV) prior to first study treatment administration.\n* History of participating any other clinical trials within 30 days prior to randomization\n* Known unable to tolerate humerus or sternal surgery or radical radiotherapy\n* Pregnancy or lactation\n* Current severe systemic disease (for example, clinically significant cardiovascular, pulmonary, or renal disease)\n* Legal incompetence or limitation.\n* Considered unable to complete the study or sign the informed consent due to a medical or mental disorder by the investigator.","FEMALE","18 Years","75 Years",{"count":21,"type":22},183,"ESTIMATED","INTERVENTIONAL",[25],"NA","A Randomized, Open Label, Phase III Trial to Evaluate Radical Local Treatment versus Palliative Treatment for Breast Cancer Patients with Primary Ipsilateral Humerus or Sternum Oligometastasis",[28,29],"Breast Cancer","Oligometastasis",[28,29,31,32],"Humerus","Sternum","RECRUITING","2020-05-09",{"date":36,"type":37},"2020-05-12","ACTUAL",{"date":34,"type":22},{"date":40,"type":22},"2026-12-31",{"name":42,"class":43},"xuexin he","OTHER",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100374699","phase-2-adjuvant-dual-anti-her2-therapy-in-patients-with-small-node-negative-her2-positive-breast-cancer-100374699","NCT04158856","Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer","Adjuvant Dual Anti-HER2 Therapy in Patients With Tumors \u003C 8mm, Node-negative, HER2-positive Breast Cancer :a Single-group Arm, Open-label, Prospective, Phase 2 Study","SHERO","Inclusion Criteria:\n\n1. Women aged 18-70 years old\n2. Have finished radical operation\n3. Histologically confirmed invasive ductal carcinoma (IDCA)\n4. According to AJCC ,pT\\\u003C8mm, pN0, no evidence for metastasis\n5. Operation specimens are available for ER, progesterone receptor (PR) and HER2 detection, patients should be HER2 positive tumor (IHC staining of 3+ \\[uniform, intense membrane staining of \\>30% of invasive tumor cells\\], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio \\[HER2 gene signals to chromosome 17 signals\\] of \\>2.2), nuclear grade 3.\n6. Should have tumor tissue available and sufficient for multi-spots sampling.\n7. It has been \\\u003C84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician.\n8. Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1, expected survival time \\> 12 months\n9. Cardiac function had to be within normal limits (left ventricular ejection fraction \\[LVEF\\] ≥50%), as established by multiple gated acquisition scan or echocardiography.\n10. Adequate bone marrow function, adequate liver and renal function, and adequate coagulation function.\n11. Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.\n12. Written informed consent according to the local ethics committee requirements.\n\nExclusion Criteria:\n\n1. pT≥8mm or node positive\n2. Metastatic breast cancer\n3. Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days\n4. With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma\n5. Patients with medical conditions that indicate intolerant to adjuvant target therapy and related treatment, including severe infection, coagulation disorder, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease\n6. Has symptomatic peripheral neuropathy \\> grade 2 according to NCI\n7. Known severe allergy to any drugs in this study\n8. Has cardiac dysfunction or lung dysfunction defined as follows:\n\n   * grade ≥3 CHF according to NCI CTCAE v 5.0 or NYHA≥II\n   * angina which requires drug control, cardiac infraction, and any other vascular disease with apparent clinical symptoms\n   * uncontrolled high-risk arrhythmia\n   * uncontrolled hypertension\n9. Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive\n10. Patient is pregnant or breast feeding","70 Years",{"count":55,"type":22},60,[57],"PHASE2","This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors \\\u003C8mm, node-negative, HER2-positive breast cancer.",[60],"HER2-positive Breast Cancer","NOT_YET_RECRUITING","2019-11-07",{"date":64,"type":37},"2019-11-12",{"date":66,"type":22},"2020-06-01",{"date":68,"type":22},"2030-05-31",{"name":42,"class":43},""]