[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-breast-cancer":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,99,126,154],{"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":25,"conditions":26,"keywords":57,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463",false,"NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","ALL","12 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","RECRUITING","2026-06-24",{"date":89,"type":90},"2026-06-26","ACTUAL",{"date":92,"type":90},"2020-10-29",{"date":94,"type":20},"2027-12-31",{"name":96,"class":97},"PMV Pharmaceuticals, Inc","INDUSTRY",77,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100568426","breast-cancer-evolution-during-neoadjuvant-systemic-therapy-100568426","NCT06681064","Breast Cancer Evolution During Neoadjuvant Systemic Therapy","BELIEVE","Inclusion Criteria:\n\n1. Histologically confirmed non-metastatic invasive breast cancer.\n2. Be suitable for, but have not commenced, neoadjuvant chemotherapy, targeted therapy, or immunotherapy.\n3. If HER2-, suitable for treatment with upfront taxane chemotherapy. If HER2+, suitable for treatment with anti-HER2 targeted therapy.\n4. Be aged 18 years and over.\n5. Have given written informed consent to participate.\n\nExclusion Criteria:\n\n1. Metastatic breast cancer at diagnosis.\n2. Treatment with neoadjuvant endocrine therapy only.\n3. Presence of any psychological, familial or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.","18 Years",{"count":108,"type":20},500,"OBSERVATIONAL","BELIEVE is a translational research study that aims to collect samples of breast cancer tissue and blood from individuals undergoing breast cancer treatment (such as chemotherapy, targeted therapy and immunotherapy) before surgery. In certain cases, MRI scans and stool samples will also be obtained before and during treatment. The samples collected from this study will be used for molecular and genetic research to understand why some cancers respond very well to anticancer treatments, and some do not, develop novel ways of accurately measuring response during treatment, as well as identify which patients are at a higher risk of the cancer coming back after surgery.",[36,48,112,50],"ER+ Breast Cancer",[114],"Neoadjuvant Therapy","2026-04-13",{"date":117,"type":90},"2026-04-16",{"date":119,"type":90},"2024-05-29",{"date":121,"type":20},"2034-05",{"name":123,"class":124},"Royal Marsden NHS Foundation Trust","OTHER",1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":106,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100480319","phase-2-a-study-on-adding-precisely-targeted-radiation-therapy-stereotactic-body-radiation-therapy-to-the-usual-treatment-approach-drug-therapy-in-people-with-breast-cancer-100480319","NCT05534438","A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer","Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression","Inclusion Criteria:\n\n* Age 18 or older\n* Willing and able to provide informed consent\n* Metastatic breast cancer, biopsy proven\n\n  * ER+\u002FHER2-, defined as \\>5% ER+ staining\n  * HER2+ (regardless of ER status), including HER2-low and high expressors\n* History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression)\n* Isolated site of disease progression on FDG PET scan\n* Consented to 12-245\n* ECOG performance status 0-1\n\nExclusion Criteria:\n\n* Pregnancy\n* Serious medical comorbidity precluding radiation, including connective tissue disorders\n* Intracranial disease (including previous intracranial involvement)\n* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.",{"count":134,"type":20},46,[24],"The purpose of this study is to see if using Stereotactic Body Radiation Therapy\u002FSBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.",[138,36,139,140,112,50],"Oligometastatic Breast Carcinoma","Metastatic Breast Cancer","Metastatic Breast Carcinoma",[142,143,112,50,139,144,145,146],"oligometastatic breast cancer","breast cancer","Stereotactic Body Radiation Therapy","22-259","Memorial Sloan Kettering Cancer Center",{"date":117,"type":90},{"date":149,"type":90},"2022-09-06",{"date":151,"type":20},"2026-09-06",{"name":146,"class":124},8,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":161,"minAge":106,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":4},"100557404","pyrotinib-combined-with-trastuzumab-subcutaneously-compared-intravenous-administration-in-the-treatment-of-her2-positive-early-breast-cancer-100557404","NCT06537674","Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer","An Exploratory Clinical Study of the PRO of Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer","Inclusion Criteria:\n\n1. Women aged ≥18 years and ≤75 years who are newly treated for breast cancer;\n2. Pathological examination confirmed HER2 positive (immunohistochemical staining ICH+++ or ICH++ and FISH positive);\n3. Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0);\n4. ECOG score 0-1;\n5. Plan to undergo the final surgical removal of breast cancer, i.e. breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND);\n6. If the major organs function normally, the following criteria are met:\n\n(1) The standard of blood routine examination should meet: ANC ≥1.5×109\u002FL; PLT ≥90×109\u002FL; Hb ≥90g\u002FL; (2) Biochemical examination should meet the following criteria: TBIL≤ upper limit of normal value (ULN); ALT and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG \\\u003C470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized, they should consent to abstinence or use an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment.\n\n8\\. Volunteer to join the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Known allergic history of the drug components of this protocol;\n2. Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);\n3. Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery;\n4. Stage IV (metastatic) breast cancer patients;\n5. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;\n6. Serious heart disease or discomfort that cannot be treated;\n7. Suffering from mental illness or psychotropic substance abuse, unable to cooperate;\n8. Pregnant or lactating women;\n9. Patients with severe liver and kidney function diseases and blood system diseases;\n10. Those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; Poor compliance and refusal to cooperate with treatment","FEMALE","75 Years",{"count":164,"type":20},100,"This study evaluated the clinical benefits of intravenous administration of pyrotinib combined with trastuzumab subcutaneous preparation by comparing the efficacy and quality of life of intravenous administration in the treatment of HER2-positive early breast cancer",[50],"NOT_YET_RECRUITING","2024-08-01",{"date":170,"type":90},"2024-08-05",{"date":172,"type":20},"2024-08-15",{"date":174,"type":20},"2026-12-30",{"name":176,"class":97},"Jiangsu Famous Medical Technology Co., Ltd."]