[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tumor-breast\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tumor-breast":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,77],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100526054","phase-2-repeat-breast-conserving-surgery-followed-by-daily-partial-breast-irradiation-in-ipsilateral-breast-100526054",false,"NCT06129747","Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast","Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation for Participants With Ipsilateral Breast Tumor Recurrence Treated Initially With Breast Conserving Surgery and Whole Breast Radiation Therapy","Inclusion Criteria:\n\n* Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies. Three years of time must have elapsed since the end of the last course of whole breast irradiation.\n* Lesion size \\\u003C 3 cm treated with a partial mastectomy. Participants with invasive cancer and clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Participants with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted.\n* Negative resection margins with at least no tumor on ink or a negative re-excision.\n* Participants with invasive recurrence must have a negative re-staging work-up consisting of either a CT chest\u002Fabdomen and a bone scan or a PET scan.\n* Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior to or after the radiation is delivered. There must be at least 2 weeks between radiation and chemotherapy. HER2 directed therapy can be delivered concurrently with radiation.\n* Participants must be \\> 18 years of age. Because no dosing or adverse event data are currently available on the use of breast re-irradiation in participants ≤18 years of age, children are excluded from this study.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n* Performance status: ECOG Performance status ≤ 2.\n* Life expectancy of ≥ 12months, in the opinion of and as documented by the investigator.\n* Not based on gender; this trial is open to any gender, defined as self-representation of gender identity.\n\nExclusion Criteria:\n\n* Participants with nodal or distant metastatic disease \\\u003C 3 years since prior radiation.\n* Participants with invasive pure lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or uncontrolled nonepithelial breast malignancies such as lymphoma or sarcoma.\n* Participants with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.\n* Participants with Paget's disease of the nipple.\n* Participants with skin involvement.\n* Participants with scleroderma or dermatomyositis.\n* Participants with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.\n* Participants who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.\n* Participants with known BRCA 1\u002FBRCA 2 mutations.","ALL","19 Years",{"count":19,"type":20},55,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.",[26,27],"Breast Cancer","Tumor, Breast",[29,30,31,32],"Radiation Therapy","In-Breast Recurrence","Tumor","Re-irradiation","RECRUITING","2026-06-24",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":37},"2023-11-30",{"date":41,"type":20},"2029-08-09",{"name":43,"class":44},"Case Comprehensive Cancer Center","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100523228","phase-2-iit2023-09-chung-upfronttad-upfront-tadsnb-in-patients-with-breast-cancer-with-nodal-metastases-100523228","NCT06092892","IIT2023-09-Chung-UpfrontTAD: Upfront TAD\u002FSNB in Patients With Breast Cancer With Nodal Metastases","IIT2023-09-Chung-UpfrontTAD: Upfront TAD\u002FSNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases","Inclusion Criteria:\n\n* Women age ≥ 45\n* Clinical T1-2N0 ER+ invasive breast cancer\n* US detected biopsy proven axillary nodal disease\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Palpable nodes on physical exam\n* Her2+ or ER- invasive breast cancer\n* Extranodal extension \\> 3 mm on nodal biopsy\n* More than 2 suspicious nodes on preoperative imaging","FEMALE","45 Years",{"count":56,"type":20},45,[23],"The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+\u002FHer2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.",[26,60,61,62,63,27],"Axillary Nodal Disease","Female Breast Cancer","Axilla; Breast","Mastectomy; Lymphedema",[65,66,67],"T1-2N0 ER+ invasive","biopsy","upfront lumpectomy","2026-05-06",{"date":70,"type":37},"2026-05-11",{"date":72,"type":37},"2024-04-07",{"date":74,"type":20},"2031-04",{"name":76,"class":44},"Alice Chung",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":98,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100535416","phase-1-trail-r2-and-her2-bi-specific-chimeric-antigen-receptor-car-t-cells-for-the-treatment-of-metastatic-breast-cancer-100535416","NCT06251544","TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer","(TRAILBLASER) TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor T Cells for the Treatment of Metastatic Breast Cancer","Procurement Inclusion Criteria:\n\n1. Any patient between 18-80 years of age regardless of sex, with a diagnosis of metastatic or locally recurrent unresectable HER2 positive breast cancer.\n2. HER2 tumor expression1+, 2+ or 3+ by IHC\n3. The disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy.\n4. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\nTreatment Inclusion Criteria:\n\n1. Patients between ages 18 and 80 years old with a diagnosis of either stage IV breast cancer or locally recurrent unresectable breast cancer. Disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy.\n2. Measurable or evaluable disease per RECIST 1.1 criteria.\n3. HER2 tumor expression 1+, 2+ or 3+ by IHC.\n4. Bilirubin ≤ 3x upper limit of normal.\n5. AST and ALT ≤ 3x upper limit of normal\n6. Hemoglobin ≥ 7 g\u002Fdl (may be transfused values)\n7. Serum creatinine \\\u003C 2 x the upper limit of normal.\n8. Pulse oximetry of \\> 90% on room air.\n9. Off conventional or investigational therapy for 3 weeks prior to study entry.\n10. ECOG Performance Status ≤ 2\n11. The patient is able to understand and give informed consent to study related procedures and treatments.\n\nProcurement Exclusion Criteria:\n\n1. Known pregnancy or actively breast feeding.\n2. Active and uncontrolled bacterial, viral, or fungal infection.\n3. Patients with current use of systemic corticosteroids (Prednisone equivalent \\>0.5mg\u002Fkg\u002Fday).\n4. Patients with abnormal left ventricular function (LVEF \\\u003C55%)\n5. Patients with brain metastases that are progressing.\n\nTreatment Exclusion Criteria:\n\n1. Pregnant or breast feeding\n2. Active and uncontrolled bacterial, viral or fungal infection\n3. Patient with current use of systemic corticosteroids (prednisone equivalent \\>0.5 mg\u002Fkg\u002Fday.\n4. Patients with abnormal left ventricular function (LVEF \\\u003C55%).\n5. Patients with brain metastases that are progressing","18 Years","80 Years",{"count":87,"type":20},27,[89],"PHASE1","The purpose of this study is to find the biggest dose of HTR2 T cells that is safe, to see how long these cells last in the body, to learn the side effects, and to see if these cells are able to fight and kill HER2 expressing breast cancer.\n\nPatients eligible for this study have metastatic breast cancer that has HER2 expression and has progressed on at least one line of therapy. This is a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that helps the body recognize and fight cancer cells.\n\nThe body has different ways of fighting diseases and no single way seems perfect for fighting cancer. This research combines two different ways of fighting cancer: antibodies and T cells. Antibodies are proteins that protect the body from infectious disease and possibly cancer. T cells, or T lymphocytes, are special blood cells that can kill other cells, including tumor cells. Both antibodies and T cells have shown promise treating cancer but have not been strong enough to cure most patients.\n\nPrevious research has found that investigators can put genes into T cells that helps them recognize cancer cells and kill them. Investigators now want to see if by putting a new gene in those T cells to help recognize breast cancer cells expressing HER2 can kill the cancer cells. In clinical trials for various cancer types that express HER2, our center engineered a CAR that recognizes HER2 and put this CAR into patients own T cells and gave them back. Investigators saw that the cells did grow and patients did tolerate and respond to the treatment.\n\nInvestigators will add a gene to the HER2 recognizing CAR T cells that will improve the T cells function. Investigators know that some immune cells in the body can lower T cells ability to kill cancer cells. Investigators have identified an antibody that will inactivate those immune suppressive cells thereby allowing T cells to survive better to recognize and kill cancer cells. This antibody targets the Trail-R2 receptor and is referred to as TR2.\n\nAlso, investigators know that T cells need the support of cytokines to perform their immune functions. There is evidence showing that the addition of interleukin 15 (IL15) enhances CAR T cells ability to kill cancer cells. As a result, investigators also added IL15 to the HER2 and TR2 targeting CAR T cells (HTR2 T cells).\n\nThe HTR2 T cells are an investigational product not approved by the Food and Drug Administration.",[26,27,92,93,94,95,96,97],"Breast Tumor","Malignant Neoplasm of Breast","Mammary Cancer","Mammary Neoplasm","Mammary Neoplasms, Human","Neoplasm, Breast",[99],"HER2 positive","NOT_YET_RECRUITING","2026-03-02",{"date":103,"type":37},"2026-03-04",{"date":105,"type":20},"2026-06",{"date":107,"type":20},"2044-01",{"name":109,"class":44},"Baylor College of Medicine",1]