[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-of-breast\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-of-breast":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,68,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100522645","cancer-pain-management-using-a-web-based-intervention-100522645",false,"NCT06085313","Cancer Pain Management Using a Web-based Intervention","Cancer Pain Management: A Technology-Based Intervention for Asian American Breast Cancer Survivors","CAI","Inclusion Criteria:\n\n* women aged 18 years and older who identify as Chinese, Korean, or Japanese;\n* have had a breast cancer diagnosis in the past;\n* can read and write English, Mandarin (simplified or traditional), Korean, or Japanese;\n* have access to the internet through computers or mobile devices (mobile phones and tablets);\n* have experienced cancer pain during the past week (at least 1 on a scale from 0 to 5 \\[no symptom=0, mild symptom that does not bother=1, somewhat bothering symptom=2, moderate symptom=3, severe symptom=4, and worst possible symptom=5\\]);\n* have experienced depressive symptoms during the past two weeks (1 to 10 on the Patient Health Questionnaire) which is equivalent to the cut-point of minimal to moderate depression.\n\nExclusion Criteria:\n\n* less than 18 years old because their cancer experience would be different from that of adults.\n* Those who are in treatment or not in treatment, but who were diagnosed with breast cancer within the past five years, will be excluded.\n* Those who participated in the PI's pilot studies will be excluded.\n* The participants of R33 phase will exclude those in active depression treatment regardless of their level of depression.\n* Those without Internet access will be excluded, but those with Internet access through community\u002Fgroup computers will be included.","FEMALE","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is funded by the HEAL Initiative (https:\u002F\u002Fheal.nih.gov\u002F). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching\u002Fsupport program for cancer pain management (CAPA) that was culturally tailored to Asian American breast cancer survivors using multiple unique features. However, CAPA rarely considered depressive symptoms accompanying pain in its design or components, and PSs indicated the necessity of further individualization of the intervention components of CAPA due to diversities in the needs of ABD. The purpose of the proposed 2-phase study is to further develop CAPA with additional components for ABD and the individual optimization functionality (CAI) and to test the efficacy of CAI in improving cancer pain experience of ABD. The specific aims are to: a) develop and evaluate CAI through an expert review and a usability test (R61 phase); b) determine whether the intervention group (that uses CAI and usual care) will show significantly greater improvements than the active control group (that uses CAPA and usual care) in primary outcomes (cancer pain management and cancer pain experience including depressive symptoms) from baseline to post 1-month and post 3-months; c) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences) that mediate the intervention effects of CAI on the primary outcomes; and d) determine whether the effects of CAI on the primary outcomes are moderated by selected background, disease, genetic, and situational factors. This study is guided by the Bandura's Theory and the stress and coping framework by Lazarus and Folkman. The R61 phase includes: (a) the intervention development process, (b) a usability test among 15 ABD, 15 family members, and 15 community gatekeepers; and (c) an expert review among 10 experts in oncology. The R33 phase adopts a randomized repeated measures control group design among 300 ABD. Long-term goals are: (a) to extend and test CAI in various healthcare settings with diverse subgroups of ABD, (b) examine the costeffectiveness, sustainability, and scalability of CAI in the settings, and (c) translate CAI into health care for ABD.",[27,28,29],"Cancer of Breast","Depressive Symptoms","Cancer Pain","RECRUITING","2026-06-06",{"date":33,"type":34},"2026-06-09","ACTUAL",{"date":36,"type":34},"2024-02-20",{"date":38,"type":21},"2027-08-31",{"name":40,"class":41},"University of Texas at Austin","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100587471","trastuzumab-emtansinet-dm1-after-trastuzumab-deruxtecant-dxd-in-her2-positive-breast-cancer-in-korea-100587471","NCT06928818","Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea","Prospective Observational Study of Trastuzumab Emtansine Immediately After Trastuzumab Deruxtecan in Patients With Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in Korea","Inclusion Criteria:\n\n* HER2-positive, advanced (unresectable locally advanced or metastatic) breast cancer\n* Prior treatment with trastuzumab deruxtecan(T-DXd) in the advanced setting\n* Intention to treat with Trastuzumab Emtansine (T-DM1) as first therapy upon T-DXd progression\n\nExclusion Criteria:\n\n* Any systemic treatment, other than T-DM1, for breast cancer after trastuzumab deruxtecan (As an exception, patients treated with endocrine agents, not in combination with cytotoxics or antibody-drug conjugates, will be permitted in the study)\n* Has been previously treated with T-DM1 for advanced breast cancer\n* Has been previously treated with 4 or more lines of therapy for advanced breast cancer\n\n  * Half (50%) or more patients will be those who were treated with second-line trastuzumab deruxtecan (i.e. patients at the later line will be capped).","ALL","19 Years",{"count":53,"type":21},100,"OBSERVATIONAL","Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea",[27,57,58],"Trastuzumab Emtansine","Trastuzumab Deruxtecan","2026-04-21",{"date":61,"type":34},"2026-04-23",{"date":63,"type":34},"2025-02-26",{"date":65,"type":21},"2029-09-30",{"name":67,"class":41},"Seoul National University Hospital",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":42},"100245694","phase-2-endocrine-treatment-alone-for-elderly-patients-with-estrogen-receptor-positive-operable-breast-cancer-and-low-recurrence-score-100245694","NCT02476786","Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score","Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score","Inclusion Criteria:\n\n* Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0.\n* Disease must be ER+ and HER2-.\n* Ki67 score\u002Fproliferative index ≤ 30% or low to intermediate mitotic index\n* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.\n* 70 years of age or older.\n* ECOG performance status ≤ 3\n* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Prior surgery for this cancer\n* A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.\n* Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.\n* Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.","70 Years",{"count":77,"type":21},50,[79],"PHASE2","Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.",[82,27,83,84],"Breast Cancer","Breast Neoplasms","Cancer of the Breast","2025-07-23",{"date":87,"type":34},"2025-07-28",{"date":89,"type":34},"2017-01-17",{"date":91,"type":21},"2032-07-31",{"name":93,"class":41},"Washington University School of Medicine",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":42},"100552329","phase-1-a-study-of-bria-ots-cellular-immunotherapy-in-metastatic-recurrent-breast-cancer-100552329","NCT06471673","A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer","Key Inclusion Criteria:\n\n1. Histological confirmed recurrent metastatic breast cancer which has failed prior\n\n   therapy defined as:\n   1. Human epidermal growth factor 2 (EGFR2, HER2) positive tumors must have failed therapy with at least 2 anti-HER2 agents\n   2. HER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy and previously treated with at least 2 hormone based targeted therapy containing regimens.\n   3. Triple-negative and inflammatory tumors must have exhausted other curative intent therapies including prior treatment with a taxane and platinum-based agent\n   4. All other MBC types must have exhausted other curative intent therapies including any genomic or germline directed targeted therapy having available approved drug(s)\n   5. Patients with new or progressive breast cancer metastatic to the brain will be eligible, provided:\n\n   i. The brain metastases must be clinically stable (without evidence of progressive disease by imaging) for at least 4 weeks, prior to first dose.\n\n   ii. There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose.\n2. Be 18 years of age or older.\n3. Have expected survival of at least 4 months.\n4. Have adequate performance status (up to and including ECOG 2)\n5. Patients must be stable with all known or expected toxicities from previous treatment including:\n\n   1. Prior immune related toxicity must not have exceeded Grade 2 with exception of stable endocrinopathy (endocrinopathy if well-managed, is not exclusionary).\n   2. Toxicity of prior therapy that has not recovered to ≤ grade 1 or baseline (with the exception of any grade of alopecia, adequately treated endocrinopathy, and anemia not requiring transfusion support).\n\nExclusion Criteria:\n\n1. Concurrent anti-cancer treatment.\n2. Recent chemotherapy, radiotherapy, or other anti-cancer treatment within 3 weeks of first protocol treatment.\n3. Participant has not recovered adequately from toxicities and\u002For complications from surgical intervention before starting study drug.\n4. History of clinical hypersensitivity to the designated therapy, as specified in the protocol or to any components used in the preparation of any cell line in this study.\n5. History of clinical hypersensitivity to any protocol specified therapy.\n6. BUN \\>30 in conjunction with a creatinine \\>2, or calculated creatinine clearance (CrCl) \\\u003C30 mL\u002Fmin (GFR can be used in place of creatinine or CrCl).\n7. Absolute granulocyte count \\\u003C 1000; platelets \\\u003C50,000.\n8. Bilirubin \\>2.0; alkaline phosphatase \\>4x upper limit of normal (ULN); ALT\u002FAST \\>2x ULN. For patients with hepatic metastases, ALT\u002FAST \\>5x ULN is exclusionary.\n9. Proteinuria \\>1+ on urinalysis or \\>1 gm\u002F24hr.\n10. New York Heart Association stage 3 or 4 cardiac disease.\n11. A pleural or pericardial effusion of moderate severity or worse.\n12. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she: agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment.\n13. Men who are fertile\u002Freproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.\n14. Women who are pregnant or nursing.\n15. Patients with concurrent second malignancy.\n16. Persons with previous malignancies requiring treatment within the past 24 months.\n17. Patients who have clinical or laboratory features indicative of AIDS and are HIV positive (by self-report).\n18. Have a diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent), or any other form of immunosuppressive therapy within 21 days prior to first dose of study treatment.\n19. Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.\n20. Patients with severe psychiatric (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator and Sponsor.\n21. Patients may not be on a concurrent clinical trial, unless approved by Investigator and Sponsor.",{"count":101,"type":21},18,[103,79],"PHASE1","This is an open-label Phase 1\u002F2a study. Once the safety of the BC1 cell line alone has been demonstrated in Phase 1, in Phase 2, patients will be treated with the Bria-OTS regimen (see below) and a clinically available check point inhibitor (CPI).\n\nDuring the monotherapy phase of Phase 1, one patient will be treated intradermally every 2 weeks for 6 weeks (4 doses) with an initial dose of the BC1 cell line. If this dose is tolerated, the next patient will receive an increased dose of BC1. If once again tolerated, the third patient will receive a further dose increase of the BC1. Once at least 3 patients have been safely treated with the BC1 cell line, with no dose-limiting toxicity (DLT), the combinational phase of the study will commence.\n\nFollowing the monotherapy phase, patients will be treated with BC1 and the Bria-OTS regimen (see below) every 3 weeks, plus a CPI at the FDA approved labelled dose and schedule. There will be at least a 2-week spacing between enrollment of each of the first three subjects in the study in order to assess for any early unanticipated risk(s).\n\nDuring the Phase 1 combination and Phase 2 expansion phases, all patients will be treated with BC1 cells as part of the Bria-OTS regimen, which includes cyclophosphamide 300 mg\u002Fm2 2-3 days prior to BC1 cell inoculation, and peginterferon alpha-2a administered on the same day, following BC1 cell inoculation.",[82,106,27,84,107,108],"Breast Tumor","Malignant Tumor of Breast","Tumors, Breast","2024-08-23",{"date":111,"type":34},"2024-08-26",{"date":113,"type":34},"2024-05-29",{"date":115,"type":21},"2025-10-30",{"name":117,"class":118},"BriaCell Therapeutics Corporation","INDUSTRY"]