[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-breast\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-breast":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100578102","phase-2-predicting-response-to-neoadjuvant-endocrine-therapy-neo-predict-100578102",false,"NCT06806930","Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)","Inclusion Criteria:\n\n* Be capable of understanding the investigational nature of the study and all pertinent aspects of the study\n* Be capable of signing and providing written consent in accordance with institutional and federal guidelines\n* Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast\n* Clinical stage 1 to 3 breast cancer\n* Candidate for surgical resection\n* Estrogen receptor \\> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.\n* HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.\n* Ability to take oral medication\n* Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff\n* Age ≥ 21 years\n\nExclusion Criteria:\n\n* Inability to comply taking NET\n* Inability to comply to study procedures","ALL","21 Years",{"count":18,"type":19},90,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called \"neoadjuvant\" treatment) affects breast cancer. The main questions the trial aims is answer are:\n\n1. How breast cancer responds to endocrine therapy given prior to surgery?\n2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C\n\nParticipants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will:\n\n* receive endocrine therapy as part of regular care for breast cancer\n* consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor\n* participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed",[25,26,27,28],"Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","Carcinoma, Breast",[30,31,32,33],"breast","cancer","HER2","carcinoma","RECRUITING","2026-02-27",{"date":37,"type":38},"2026-03-03","ACTUAL",{"date":40,"type":38},"2024-10-01",{"date":42,"type":19},"2028-10",{"name":44,"class":45},"George Washington University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100423165","phase-4-effect-of-huaier-granule-on-adjuvant-treatment-for-high-risk-early-stage-triple-negative-breast-cancer-100423165","NCT04790305","Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer","Effect of Huaier Granule on Postoperative Adjuvant Treatment for High-risk Early-stage Triple-negative Invasive Ductal Carcinoma: a Prospective, Multicenter, Randomized, Controlled, Open-label Study","Inclusion Criteria:\n\n1. Aged from 18 to 70.\n2. Histologically confirmed as breast invasive ductal carcinoma.\n3. Molecular typing of breast lesions is triple-negative breast cancer, when the patient had multicentric lesions at the same time, all invasive lesions were confirmed as triple-negative.\n4. Regional lymph node metastasis confirmed by postoperative pathology \\[except isolated tumor cells ( ITC )\\], or tumor response did not achieve pathological complete response (pCR) after neoadjuvant therapy \\[neoadjuvant chemotherapy completed at least four cycles, the breast has residual invasive cancer or axillary lymph node metastasis ( except isolated tumor cells ) .\\]\n5. There was no local recurrence and distant metastasis of the tumor.\n6. The time of randomization is during the postoperative adjuvant therapy or within 60 days after the end of the last postoperative adjuvant therapy.\n7. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1.\n8. Hepatic function and renal function: serum creatinine level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) concentration \u002F alanine aminotransferase (ALT) concentration≤ 2.5 × ULN，total serum bilirubin concentration≤ 1.5 × ULN.\n9. Blood routine: neutrophil count ≥ 1.5\\*109 \u002F L, platelet count ≥ 100\\*109 \u002F L, hemoglobin concentration ≥ 90 g \u002F L (without transfusion).\n10. The participants volunteered to join the study with good compliance and signed an informed consent form.\n\nExclusion Criteria:\n\n1. Bilateral breast cancer.\n2. Complicated with severe cardiopathy, hepatopathy, nephropathy, endocrine system diseases. According to the researchers' judgement, the comorbidities can cause unacceptable safety risks and affect participants' compliance with research programs.\n3. Suffering from malignant tumors other than breast cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the past 5 years.\n4. Allergic to Huaier granule.\n5. Pregnant or lactating women, and those who planning a pregnancy during the study period.\n6. Participating in other clinical trials or participated in other clinical studies within 3 months.\n7. Patients with a poor compliance, or they are not appropriate for this study because of other reasons considered by the researchers.","18 Years","70 Years",{"count":57,"type":19},1072,[59],"PHASE4","This is a prospective, multicenter, randomized, parallel controlled, open-label study. The primary purpose of this study is to evaluate the efficacy of Huaier Granule on postoperative adjuvant therapy of high-risk early-stage triple-negative invasive ductal carcinoma. The Secondary purposes are to evaluate the safety of long-term use of Huaier granules as postoperative adjuvant treatment of high-risk early-stage triple-negative invasive ductal carcinoma, and the changes of quality of life score after treatment with Huaier granule.",[62,63,64],"Carcinoma Breast","Triple-negative Breast Cancer","Invasive Ductal Carcinoma, Breast",[66,63,64,67],"Huaier Granule","Adjuvant Treatment","2024-06-25",{"date":70,"type":38},"2024-06-27",{"date":72,"type":38},"2021-06-18",{"date":74,"type":19},"2028-07-28",{"name":76,"class":45},"Fudan University",34]