[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mammary-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mammary-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100535416","phase-1-trail-r2-and-her2-bi-specific-chimeric-antigen-receptor-car-t-cells-for-the-treatment-of-metastatic-breast-cancer-100535416",false,"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","ALL","18 Years","80 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33,34],"Breast Cancer","Tumor, Breast","Breast Tumor","Malignant Neoplasm of Breast","Mammary Cancer","Mammary Neoplasm","Mammary Neoplasms, Human","Neoplasm, Breast",[36],"HER2 positive","NOT_YET_RECRUITING","2026-03-02",{"date":40,"type":41},"2026-03-04","ACTUAL",{"date":43,"type":21},"2026-06",{"date":45,"type":21},"2044-01",{"name":47,"class":48},"Baylor College of Medicine","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":49},"100536733","phase-2-tart-cherry-juice-as-a-dietary-supplement-for-the-prevention-of-paclitaxel-induced-neuropathy-100536733","NCT06268665","Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","Inclusion Criteria:\n\n* Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria.\n* Must be planning to receive paclitaxel weekly for 12 weeks (12 weeks total) as part of neoadjuvant, adjuvant, or metastatic cancer treatment.\n\n  * Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) is allowed.\n  * Currently receiving hormone therapy, bisphosphonates, denosumab or LHRH-agonists is allowed.\n  * Concurrent use of immune checkpoint inhibitor therapy is allowed.\n  * (Neo)adjuvant chemotherapy with doxorubicin and cyclophosphamide is allowed.\n  * Concurrent use of carboplatin with weekly paclitaxel in the study is allowed.\n* May participate concurrently in other cancer trials.\n* Must be able to complete questionnaires in English or Spanish.\n* Age ≥ 18 years old at the time of consent.\n* ECOG performance status of 0 - 1 (Karnofsky scale ≥ 70%, see Appendix).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Individuals of child-bearing potential must agree to use birth control (e.g., hormonal or barrier method; abstinence, an intrauterine device) prior - to study entry, for the duration of study participation (including dose interruptions), and for 3 months after the last dose of tart cherry juice supplement; or be surgically sterilized (e.g., hysterectomy or tubal ligation).\n* Patients with known human immunodeficiency virus (HIV) are allowed in the study, but HIV-positive patients must have:\n\n  * A stable regimen of highly active anti-retroviral therapy (HAART)\n  * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n  * A CD4 count above 250 cells\u002FµL and an undetectable HIV viral load on standard PCR-based tests within the last year.\n* Stated willingness to not drink any additional tart cherry or any cherry juice while on the study.\n* Ability and willingness to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum. Doxorubicin is allowed (≥ 2 week washout period required).\n* Active or history of peripheral neuropathy, or any chronic diseases associated with peripheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus.\n* Currently taking anticoagulant medication.\n* Currently taking Vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline or duloxetine. If a patient is taking any of these supplements\u002Fmedications, they must agree to stop at the time of registration. Multivitamins containing Vitamin E are allowed, however Vitamin E \\> 1,000 international units (IU) must be discontinued at the time of registration.\n* Patients may not use cold therapy gloves for chemotherapy induced neuropathy.\n* Known allergy to cherries.\n* Inability to swallow liquid.\n* Pregnant or breastfeeding individuals (lactating individuals must agree not to breast feed while taking study juice supplementation).\n* Any condition that would prohibit the understanding or rendering of informed consent.\n* Any condition that in the opinion of the investigator would interfere with safety or compliance while on trial.",{"count":58,"type":21},86,[60],"PHASE2","This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.\n\nEligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).",[27,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,31,90,91,92,93,94,95,96,97],"Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","Breast Cancer Stage IV","Invasive Breast Cancer","Ovarian Cancer","Ovarian Cancer Stage 1","Ovarian Cancer Stage II","Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Ovarian Cancer Stage IA","Ovarian Cancer Stage IB","Ovarian Cancer Stage IC","Ovarian Cancer Stage 2","Ovarian Cancer Stage 3","Ovarian Cancer Stage IIIb","Ovarian Cancer Stage IIIC","Breast Cancer Stage IIIA","Breast Cancer Invasive","Breast Cancer, Stage IA","Breast Cancer, Stage IB","Breast Cancer Stage IIA","Breast Cancer Stage IIB","Breast Cancer Stage IIIB","Breast Cancer Stage IIIc","Cancer, Breast","Tumors, Breast","Mammary Carcinoma","Breast Carcinoma","Breast Neoplasm","Malignant Breast Neoplasm","Malignant Tumor of Breast","Cancer of Ovary","Ovary Cancer","Ovary Neoplasm","RECRUITING",{"date":40,"type":41},{"date":101,"type":41},"2024-08-15",{"date":103,"type":21},"2027-12",{"name":105,"class":48},"University of California, Davis",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":113,"minAge":114,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":49},"100385643","phase-2-omission-of-surgery-and-sentinel-lymph-node-dissection-in-clinically-low-risk-her2positive-breast-cancer-with-high-her2-addiction-and-a-complete-response-following-standard-anti--her2-based-neoadjuvant-therapy-elpis-trial-100385643","NCT04301375","Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti- HER2-based Neoadjuvant Therapy (ELPIS Trial)","ELPIS","Inclusion Criteria:\n\n* Female participants who are at least 40 years of age on the day of signing the informed consent form with histologically confirmed diagnosis of breast cancer.\n* A participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  1. Not a woman of childbearing potential as defined in protocol OR\n  2. A woman of childbearing potential who agrees to follow the contraceptive guidance in protocol during the treatment period and for at least 7 months after the last dose of study treatment\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Histologically confirmed invasive adenocarcinoma of the breast, with all of the following characteristics:\n\n  * HER2-positive status by local determination according to 2018 American Society of Clinical Oncology \u002F\u002FCollege of American Pathologists guidelines.\n  * PAM50 HER2-enriched subtype and ERBB2-high as predefined cutoff as per central determination.\n  * Unifocal invasive carcinoma: only 1 invasive focus can be observed (the tumor focus containing or not containing an in situ component)\n  * Tumor largest diameter ≤2 cm as defined by breast Magnetic resonance imaging.\n  * No nodal involvement (i.e. cN0). Any suspicious axillary node by ultrasound must be biopsied. If the biopsy or the fine-needle aspiration is negative of tumor cells, patient is eligible.\n  * No evidence of distant metastasis (M0) by routine clinical assessment.\n* Patient must have known estrogen receptor and progesterone receptor status locally determined prior to study entry\n* Eligible for taxane therapy\n* Willingness of the patient to omit surgery if all criteria are met following neoadjuvant therapy\n* Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.\n* Breast cancer eligible for primary surgery\n* Have provided archival tumor tissue sample or newly obtained core. Formalin-fixed, paraffin embedded tissue blocks are mandatory. Available pre-treatment Formalin-fixed, paraffin embedded core biopsy evaluable for PAM50 or possibility to obtain one.\n* Have an Eastern Cooperative Oncology Group performance status of 0 to 1. Evaluation of Eastern Cooperative Oncology Group is to be performed within 7 days prior to the date of allocation\n* Ability and willingness to comply with study visits, treatment, testing and to comply with the protocol.\n* Have adequate organ function as defined in the protocol. Specimens must be collected within 10 days prior to the start of study treatment\n\nExclusion Criteria:\n\n* A woman of childbearing potential who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has received prior anti-cancer therapy, including investigational agents, or treatment for primary invasive breast cancer.\n* Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, TDM1 or paclitaxel.\n* Clinical stage II, III or IV\n* History of radiotherapy in the ipsilateral breast or axilla\n* History of surgery of the ipsilateral axilla\n* Bilateral invasive breast cancer\n* Infiltrating lobular carcinoma.\n* Multicentric or multifocal breast cancer, defined as the presence of two or more foci of cancer in the same or different quadrants of the same breast.\n* Patients who have undergone sentinel lymph node biopsy prior to study treatment.\n* Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:\n\n  * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 12 months prior to screening.\n  * History of documented congestive heart failure (New York Heart Association functional classification III-IV).\n  * Documented cardiomyopathy.\n  * Patient has a Left Ventricular Ejection Fraction \\\u003C 55% at baseline as determined by Multiple Gated acquisition scan or echocardiogram.\n  * Clinical significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular block (e.g. bifascicular block, Mobitz type II and third-degree atrioventricular block)\n  * Long QT Syndrome or family history of idiopathic sudden death or congenital long QT syndrome or any of the following: o Risk factors for Torsades de Pointe including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant\u002Fsymptomatic bradycardia\n  * Corrected QT\\> 500 msec or conduction abnormality in the previous 12 months.\n* Has an active infection requiring systemic therapy.\n* Patients with a history of previous breast cancer are excluded. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years are excluded. For patients with a history of other non-breast cancers within 5 years and considered of very low risk of recurrence per investigator's judgment (for example, papillary thyroid cancer treated with surgery), eligibility is to be discussed with Study Medical Monitor.\n* Has a known history of Human Immunodeficiency Virus. Note: No HIV testing is required.\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen reactive) or known active Hepatitis C virus (defined as Hepatitis C virus RNA is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of trial treatment.\n* Patients currently on following medications, which cannot be interrupted 7 days prior treatment start:\n\n  * Any prohibited medication as per trastuzumab, pertuzumab or paclitaxel label.\n  * Herbal preparations\u002Fmedications, dietary supplements.","FEMALE","40 Years",{"count":20,"type":21},[60],"This is a prospective, single arm, open-label, exploratory study in women with primary operable HER2-positive, HER2-enriched(HER2-E)\u002FERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel\u002Ftrastuzumab\u002Fpertuzumab.",[31],"2020-03-05",{"date":121,"type":41},"2020-03-10",{"date":123,"type":21},"2020-06-15",{"date":125,"type":21},"2027-07-15",{"name":127,"class":48},"David Garcia Cinca"]