[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pravin T.P Kaumaya\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100589053","phase-1-her2-vaccine-for-locally-advanced-breast-cancer-100589053",false,"NCT06949410","HER2 Vaccine for Locally Advanced Breast Cancer","Phase I Trial of a Chimeric (Trastuzumab-like and Pertuzumab-like) HER2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant for Locally Advanced HER2 Positive Breast Cancer","Inclusion Criteria:\n\n1. ≥ 18 years old at the time of informed consent\n2. Ability to provide written informed consent and HIPAA authorization CTO-IUSCC-0864\n3. Histologically confirmed HER2 positive breast cancer\n\n   1. Any Estrogen Receptor\u002FProgesterone Receptor status is allowed.\n   2. HER2 positive is defined as HER2 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \\> 2.0 or \\> 6 total HER2 gene copies per cell.\n4. High-risk disease defined as one of the following:\n\n   1. Any residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant taxane and trastuzumab-based chemotherapy\n   2. Inflammatory phenotype at the time of diagnosis per the treating physician\n   3. Clinical stage III disease at the time of diagnosis per the treating physician and\u002For clinical imaging\n   4. Locally recurrent disease and have undergone definitive local therapy\n5. Received at least six months of HER2 targeted therapy with trastuzmab +\u002F- pertuzumab TDM-1, or others in the neoadjuvant or adjuvant setting\n\n   a. Any combination of HER2 targeted therapy in the curative setting is allowed, including neratinib or others on a clinical trial\n6. Completed last dose of HER2 targeted therapy no more than 6 months prior to registration\n7. Completed last dose of cytotoxic chemotherapy or radiation at least 30 days prior to registration with resolution of any prior toxicity to ≤ 2 with the exception of alopecia\n8. ECOG performance status of 0 to 2\n9. Adequate organ function as indicated by:\n\n   1. Total bilirubin \\\u003C 1.5 mg\u002FdL (except in patients with documented Gilbert's disease, who must have a total bilirubin \\\u003C 3.0 mg\u002FdL)\n   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.0 x ULN\n   3. Calculated creatinine clearance of \\> 60 mL\u002Fmin using the Cockcroft-Gault formula\n   4. Absolute neutrophil count (ANC) \\> 1.0 K\u002Fmm3\n   5. Platelets \\> 100 K\u002F mm3\n10. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) above the institutional lower limit of normal by echocardiogram or MUGA obtained within 90 days of registration\n11. Women of childbearing potential must have a negative serum pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:\n\n    1. Has undergone a hysterectomy or bilateral oophorectomy; or\n    2. Has been naturally amenorrheic for at least 12 consecutive months.\n12. Women of childbearing potential and men must agree to use one effective contraception throughout the study and for 6 months after the last study treatment.\n\nNote: Acceptable methods of birth control include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).\n\nExclusion Criteria:\n\n1. Any distant disease recurrence.\n2. Patients with active malignancy other than breast cancer. Note: Patients with prior malignancies without recurrence after standard treatment will not be excluded.\n3. Patients receiving or planned to receive adjuvant CDK4\u002F6 inhibitor therapy\n4. Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.\n5. Patients who require or likely to require corticosteroids or other immunosuppressives\n6. Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome.\n\n   Note: At the discretion of the treating physician, patients who show disease control for at least 6 months and do not require immunosuppressives may be enrolled.\n7. Patients who have developed anaphylactic responses to other vaccines.\n8. Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection.\n9. Known seropositive or active viral infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV). Seropositivity due to vaccination are eligible.\n10. Uncontrolled illness that would limit safety or compliance with study procedures including, but not limited to, active infection, congestive heart failure, unstable angina, or cardiac arrhythmia.\n11. Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases. At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.\n12. History of splenectomy\n13. Pregnant or breast feeding.","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.",[26,27],"Breast Cancer","HER2-positive Breast Cancer",[29,30,31],"vaccine","immune system","immunotherapy","RECRUITING","2026-04-21",{"date":35,"type":36},"2026-04-22","ACTUAL",{"date":38,"type":20},"2026-06",{"date":40,"type":20},"2030-03",{"name":42,"class":43},"Pravin T.P Kaumaya","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100547957","phase-1-her-2-b-cell-peptide-vaccine-100547957","NCT06414733","HER-2 B Cell Peptide Vaccine","Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nInclusion Criteria for Extension and Expansion Cohorts\n\n1. For the extension cohort to be conducted at the IUSCCC (N=12), patients with histologically documented metastatic or unresectable breast or gastrointestinal cancer will be enrolled.\n2. For the expansion cohort (N=30), patients with either histologically documented metastatic or unresectable breast cancer (N=15), or histologically documented metastatic or unresectable gastrointestinal cancer (N=15) be enrolled. All patients enrolled to this cohort are required to have measurable disease. Note: Measurable disease is defined as ≥ 1 lesions that can be accurately measured in ≥ 1 dimensions as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.\n\n   Inclusion Criteria for all Cohorts:\n3. Patients must have received or refused first line standard systemic therapy for their metastases (if applicable) and patients with histologically confirmed pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years after standard therapy. Patients with histologically confirmed breast, and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy.\n4. Progressive disease after at least one line of standard therapy.\n5. Patients with pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years. Patients with breast and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years.\n6. Patients are required to have HER-2 (IHC 1+, 2+ and 3+) or EGFR over-expression (FISH and IHC) to be enrolled on this study.\n\n   1. If the patient has had HER-2 expression measured prior to enrollment, the report alone will be accepted on the expansion phase of the study.\n   2. If the patient has had EGFR expression measured prior to enrollment, the report alone will be accepted on the dose escalation phase of the study.\n   3. If the patient has not had HER-2 or EGFR expression measured prior to enrollment on this study, it would be obligatory for the patient to have the tests performed to justify their status. HER-2 status can be performed by a variety of tests. Either IHC or FISH assay are acceptable if breast tumor tissues (previously frozen) are available. The test can be done at IUSCCC or elsewhere if the patient is from out of town.\n7. Patients with prior history of treated brain metastases who are off steroids and have stable metastatic brain disease for at least 3 months are eligible.\n8. Patients must be ambulatory with an ECOG performance status 0, 1, or 2 (appendix II).\n9. Patients must have adequate organ function as defined by:\n\n   1. ANC ≥ 1,000\u002Fmm³, platelet count \\> 700,000\u002Fmm³.\n   2. Serum bilirubin \\\u003C 1.5 mg%, regardless of whether patients have liver involvement secondary to tumor. ALT must be \\\u003C 2 times upper limit of normal.\n   3. Creatinine \\\u003C1.5 mg\u002Fdl or calculated creatinine clearance \\> 60 ml\u002Fmin\n10. Patients must be at least 3 weeks past any prior surgery, cytotoxic, chemotherapy, other immunotherapy, hormonal therapy, or radiation therapy. Patients having been treated with monoclonal antibodies may enter the trial after a specified period of time (2 times the mean half life of the agent). Patients must have recovered from any toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to less than grade 2.\n\n    1. Patients with hormone receptor positive breast cancer who are on stable endocrine therapy are eligible if their tumor has some expression of HER-2 based on IHC of 1+ or 2+.\n11. Patients must be at least 18 years of age.\n12. Women of child-bearing potential must not be pregnant and must have a negative pregnancy test (Women of childbearing potential definition: (ECOG definition)).\n13. Men and women must agree to practice effective contraception while on this study.\n14. Patients must obtain a base line Echocardiogram or MUGA and require the left ventricular ejection fraction to be within normal limits (or 50% or higher).\n15. Ability to understand and the willingness to sign a written informed consent document.\n\nThe patient must be aware that his\u002Fher disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.\n\nExclusion Criteria:\n\n1. Patients with tumors that are negative for HER-2 expression based on IHC of 0 AND Fluorescence in-situ hybridization showing lack of HER-2 amplification based on most recent ASCO\u002FCAP guidelines; or are under-expressing EGFR based on FISH and IHC.\n2. Patients on targeted therapies, such as Cycline Dependent Kinase (CDK) 4\u002F6 or mammalian target of rapamycin (mTOR) inhibitors in combination with endocrine therapy\n3. Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.\n4. Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection.\n5. Patients with known active HIV, hepatitis A, hepatitis B, or hepatitis C infection.\n6. Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases. At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.\n7. Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible.\n8. Splenectomized patients.\n9. Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome.\n\n   Note: At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.\n10. Patients who have developed anaphylactic responses to other vaccines",{"count":53,"type":20},42,[23],"This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.",[57,58,27,59,60],"Metastatic Breast Cancer","Metastatic Gastrointestinal Carcinoma","HER2-positive Gastric Cancer","EGFR Overexpression",[62,26,63],"Phase I","GI Cancer","2025-08-19",{"date":66,"type":36},"2025-08-24",{"date":68,"type":36},"2025-01-17",{"date":70,"type":20},"2030-12-31",{"name":42,"class":43},""]