[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"invasive-ductal-carcinoma-breast\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:invasive-ductal-carcinoma-breast":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":47},"100369008","phase-2-study-of-3-day-partial-breast-radiation-therapy-in-women-with-breast-cancer-100369008",false,"NCT04084730","Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer","Ultra-Short External Beam-Based Accelerated Partial Breast Irradiation (APBI): A Phase II Toxicity Study Nested With a Non-inferiority Assessment of APBI in New Patient Cohorts","Inclusion Criteria:\n\n* Female\n* Age \\>\u002F= 45 years\n* Unicentric pathological stage I (pT1 or T2 pN0\\_M0) invasive ductal breast cancer or DCIS measuring \\\u003C3 cm in longest diameter on pathology and\u002For mammogram that is histologically confirmed. If T2, the tumor must be less than 3cm in longest diameter. Note: Women ≥ 70 years or older with T1 invasive ductal carcinoma who are estrogen- receptor positive (ER+) with clinically negative axillary nodes, and do not undergo surgical lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible. Patients age 50 or older who are clinically node-negative by physical exam and ultrasound and have a primary tumor that is \\\u003C=2 cm and hormone-receptor positive, are also eligible.\n* Histologically negative tumor margin or no tumor in a re-excision specimen on final shaved specimen.\n* ECOG Performance Status of 0 or 1.\n* Negative serum pregnancy test within 14 days prior to study treatment if a woman has child-bearing potential. Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year\n* Written informed consent obtained from subject and ability for subject or comply with the requirements of the study\n* Female subjects of childbearing potential should be willing to use 2 methods or birth control or be surgically sterile or abstain from heterosexual activity for the duration of study participation. Should a woman become pregnant while participating on study, she should inform the treating physician immediately.\n\nInclusion Criteria for intermediate risk substudy:\n\n* Post-NAC cohort patients: clinical T1-T2 (less than or equal to 5cm in longest diameter on available imaging) and clinical N0-N1 (on exam and imaging) with pathological ypT0, ypTis, or ypT1 (\\\u003C=2cm) and ypN0 (any regimen of neoadjuvant chemotherapy agents is allowed)\n\nOR\n\n* Oncotype RS score of 26 or higher\n\nOR\n\n* PAM50 ROR scored as \"HIGH\"\n\nOR\n\n* Presence or LVI (focal, limited or \"not otherwise specified\") in the lumpectomy specimen\n\nOR\n\n* Age 40-49 years (ALL OF THE FOLLOWING MUST BE TRUE : 1) no history of prior benign breast biopsies, 2) no concomitant or prior atypia in either breast, 3) no concomitant or prior LCIS in either breast, 4) no family history of breast cancer in first degree relatives)\n\nOR\n\n* Invasive lobular carcinoma\n\nOR\n\n* Surgical margins less than 1 mm to invasive or in-situ disease.\n\nExclusion Criteria:\n\n* Patients with distant metastasis\n* Patients who are pregnant or breastfeeding\n* Patients with diffuse (\\>1 quadrant or \\>5cm) suspicious microcalcifications or patients with known multicentric OR multifocal disease. (microscopic multifocal disease that may be unifocal and\u002For appear multifocal due to sectioning is allowed after review with PI).\n* Prior radiation therapy to the ipsilateral or contralateral breast or thorax.\n* Histological evidence of extensive lymphovascular invasion (LVI)\n* Histological evidence of extensive intraductal component (EIC), defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumo area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor.\n* Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. Note: in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study. It would be an extremely rare\u002Funlikely scenario for patients to be discovered BRCA positive after the completion of PBI, as all patients with risk factors for BRCA mutations (positive family history, Ashkenazi Jewish descent, ER-\u002FPR-\u002Fher2-neu-negative receptor status) are usually tested prior to radiation. Should such a situation exist, these patients will be given the option of remaining on the breast conservation paradigm or opting for mastectomy (as is done in this rare scenario is standard of care practice). The patient will be replaced on the trial.\n* History of cosmetic or reconstructive breast surgery.\n* Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.\n* Patients with a \"currently active\" second malignancy other than non-melanoma skin cancers. Patients are not considered to have \"currently active\" malignancies if they have completed therapy and are considered by their physicians to be at \\\u003C5% risk of relapse within 3 years.\n* Patients who are already enrolled in or planning to enroll in other adjuvant systemic therapy protocols for both non-invasive or invasive breast cancer\n* Expecting to conceive within the projected duration of the trials, starting with screening visit through 180 days after the last dose of trial treatment\n* Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. Bisphosponates are permitted without restriction even during protocol treatment. Note: This does not apply to hormonal therapies such as tamoxifen or AIs, which are permitted. This does not apply to anti-Her2 therapies such as trastuzumab or TDM-1, which are also permitted.\n* Ongoing therapy with other investigational agents. Patients may not be receiving any other investigational agents.","FEMALE","45 Years",{"count":19,"type":20},280,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.",[26,27,28,29,30,31],"Invasive Ductal Breast Carcinoma","Invasive Ductal Carcinoma, Breast","DCIS","DCIS Grade 1","DCIS Grade 2","Breast Cancer",[33,31,34,35],"Unicentric pathological stage I breast invasive ductal breast cancer","Memorial Sloan Kettering Cancer Center","19-300","RECRUITING","2025-09-15",{"date":39,"type":40},"2025-09-16","ACTUAL",{"date":42,"type":40},"2019-08-30",{"date":44,"type":20},"2026-08-30",{"name":34,"class":46},"OTHER",9,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"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.","ALL","18 Years","70 Years",{"count":59,"type":20},1072,[61],"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.",[64,65,27],"Carcinoma Breast","Triple-negative Breast Cancer",[67,65,27,68],"Huaier Granule","Adjuvant Treatment","2024-06-25",{"date":71,"type":40},"2024-06-27",{"date":73,"type":40},"2021-06-18",{"date":75,"type":20},"2028-07-28",{"name":77,"class":46},"Fudan University",34]