[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her-2-low-expressing-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her-2-low-expressing-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,57,85,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100579768","early-phase-1-pilot-study-of-68gaga-aby-025-imaging-in-patients-undergoing-treatment-with-her2-targeted-therapy-100579768",false,"NCT06828588","Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the discretion of their treating physician for an FDA-approved indication. Patients who are planning to start HER2-targeted therapy at the time of study enrollment. Patients who have recently begun HER2 treatment and have received no more than 6 cycles will be eligible for enrollment.\n3. Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type.\n4. Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.\n5. Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study.\n\nExclusion Criteria:\n\n1. Measurable sites of disease only in the liver.\n2. Inability to comply with study procedures.\n3. Hypersensitivity or allergy to any component of \\[68Ga\\]Ga-ABY-025.\n4. Pregnant or breastfeeding.\n5. HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.\n6. Inability to lie flat for 30 minutes during an imaging session.\n7. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","The purpose of this study is to determine if the radiotracer, \\[68Ga\\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.",[25,26,27,28,29],"Locally Advanced Cancer","Metastatic Cancer","HER2","HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma","HER 2 Low-expressing Breast Cancer",[27,31,32,33,34,35,36,37,38,39,40,41,42,43],"cancer","advanced cancer","metastatic","IHC","FISH","trastuzumab","T-DM1","Pertuzumab","Margetuximab","Neratinib","Lapatinib","Tucatinib","Everolimus","RECRUITING","2026-05-06",{"date":47,"type":48},"2026-05-08","ACTUAL",{"date":50,"type":48},"2026-04-16",{"date":52,"type":19},"2029-12",{"name":54,"class":55},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":20,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":56},"100602963","percist-evaluation-of-trastuzumab-deruxtecan-in-the-treatment-of-her2-low-breast-cancer-100602963","NCT07130344","PERCIST Evaluation of Trastuzumab Deruxtecan in the Treatment of HER2 Low Breast Cancer","PERPETUAL","Inclusion Criteria:\n\n1. Age greater than or equal to 18 years at inclusion\n2. Cytological or histological confirmation of the diagnosis of low HER2 breast cancer (IHC 1+ or 2+ with non-amplified FISH\u002FSIS)\n3. Metastatic disease according to RECIST 1.1\n4. Indication of T-DXd treatment\n5. Patient (male or female of childbearing potential) using a highly effective contraceptive method\n6. Women of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment\n7. Willingness and ability to comply with the visit schedule, treatment regimens, examinations and other procedures planned in the study\n8. Patient enrolled in a health insurance plan or beneficiary of such a plan\n9. Signed informed consent obtained before inclusion (after giving clear, fair and appropriate information)\n\nExclusion Criteria:\n\n1. Allergy to contrast dye\n2. Contra-indication to PET-CT\n3. Any active infection or uncontrolled intercurrent pathology\n4. Patient with a life expectancy lower than 3 months\n5. Ongoing participation in another clinical trial with an investigational treatment\n6. Pregnant or breastfeeding women\n7. Persons deprived of their freedom or under guardianship or incapable of giving consent\n8. Any psychiatric illness\u002Fsocial situation that may limit compliance with study procedures or prevent the patient from giving written informed consent",{"count":65,"type":19},262,[67],"NA","The development of trastuzumab deruxtecan (T-DXd), an anti-HER2 conjugated antibody, has changed the therapeutic landscape of breast cancer. Anti-HER2 molecules were previously used exclusively in cases of HER2-positive breast cancer (IHC HER2 3+ or HER2 2+ with amplified FISH\u002FSISH).\n\nSince a couple of years, T-DXd is becoming a reference treatment in patients with low HER2 breast cancer (IHC 1+ or 2+ with non-amplified FISH\u002FSISH) after hormone therapy and at least one line of chemotherapy. The results of the DB04 trial revealed that T-DXd increased progression-free survival and overall survival compared to investigator's choice chemotherapy, in HER2 low breast cancers patients after one or two previous lines of chemotherapy (Modi, S. et al., 2022).\n\nIn several trials, T-DXd validation was done thanks to radiological evaluation based on conventional imaging, computed tomography scan (CT-scan) with or without contrast dye injection and bone scintigraphy.\n\n18F-Fluorodeoxyglucose positron emission tomography coupled with computed tomography (18F-FDG PET-CT) represents a major tool for diagnosis, staging, and therapeutic follow-up in oncology.\n\nIt was demonstrated that 18F-FDG PET-CT is more sensitive in detecting metastatic disease progression in HER2-positive breast cancer patients treated with trastuzumab and pertuzumab or trastuzumab and lapatinib (Ma, G. et al., 2023 et Lin, N. U. et al., 2015). Moreover, a prospective study investigated the correlation between the response rate defined by 18F-FDG PET-CT and thoraco-abdomino-pelvic CT-scan (TAP CT-scan) and the progression-free survival of patients with breast cancer. PET evaluation allowed better identification of responders versus non-responders, with a significant correlation with progression-free survival (Vogsen, M. et al., 2023).\n\nWith this study, the investigators aim to determine the role of 18F-FDG PET-CT in evaluating T-DXd treatment in patients with metastatic low HER2 breast cancer. 18F-FDG PET-CT could be an earlier evaluation tool than CT-scan in identifying non-responsive patients; and thus, avoid continuing an expensive treatment with an unfavorable toxicity profile, which could worsen both patient prognosis and quality of life.",[70,29],"Metastatic Breast Cancer",[72,73,74],"Breast Cancer","18F-FDG PET-CT","T-DXd","NOT_YET_RECRUITING","2025-09-03",{"date":78,"type":48},"2025-09-10",{"date":80,"type":19},"2025-09",{"date":82,"type":19},"2030-09",{"name":84,"class":55},"Centre Paul Strauss",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":20,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100604597","phase-2-testing-two-different-drugs-sacituzumab-govitecan-and-trastuzumab-deruxtecan-combinations-prescribed-in-an-alterning-pattern-to-patients-with-metastatic-or-locally-advanced-triple-negative-breast-cancer-100604597","NCT07151586","Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer","A Phase 2, Multicenter, Randomized, Open-label Trial Assessing Sacituzumab-govitecan and Trastuzumab-deruxtecan Combinations in an Alternating Regimen for Patients With Metastatic or Locally Advanced HER2-low Triple-negative Breast Cancer","ALTER","Inclusion Criteria:\n\n* Patient must have signed a written informed consent prior to any trial specific procedures. (Note : When the patient is physically unable to give his\u002Fher written consent, a impartial witness of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent)\n* Men or women ≥ 18 years of age\n* Histologically confirmed metastatic or locally advanced and unresectable triple-negative breast cancer, meeting both of the following criteria by local testing:\n\nHER2-low breast cancer, defined as either immunohistochemistry (IHC) 2+ \u002F in situ hybridization (ISH)-negative or IHC 1+ (ISH-negative or untested), on either the primary or any metastatic site\n\nEstrogen receptor (ER) expression \\\u003C10% and progesterone receptor (PR) expression \\\u003C10% (Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours correspond to a triple-negative breast cancer meeting the above criteria)\n\n* Patient eligible to receive sacituzumab-govitecan and T-Dxd according to their indication\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n* Women of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment for women and up to 4 months for men.\n\nA woman is considered to be of childbearing potential if she is not postmenopausal or has not undergone hysterectomy. Postmenopausal is defined as any of the following:\n\nAge ≥ 60 years Age \\\u003C 60 years and ≥ 12 continuous months of amenorrhea with no identified cause other than menopause Surgical sterilization (bilateral oophorectomy)\n\n\\- Adequate organ and bone marrow function within 28 days before enrollment. The most recent results available must be used for all parameters below:\n\nHemoglobin ≥ 9 g\u002FdL. Red blood cell transfusion is not allowed within 1 week prior to screening assessment\n\nAbsolute neutrophil count (ANC) ≥ 1,500\u002Fmm³. Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment\n\nPlatelet count ≥ 100,000\u002Fmm³. Platelet transfusion is not allowed within 1 week prior to registration\n\nTotal bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases, or \\\u003C 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastasis at baseline\n\nAlanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, or \\\u003C 5 × ULN in patients with liver metastasis\n\nSerum albumin ≥ 2.5 g\u002FdL\n\nCreatinine clearance (CrCl) ≥ 30 mL\u002Fmin, calculated using the Cockcroft-Gault equation: CrCl (mL\u002Fmin) = \\[(140 - age in years) × weight in kg\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\] (× 0.85 for females)\n\n* Adequate cardiac function, defined as a left ventricular ejection fraction ≥ 55% estimated by echocardiogram or multigated acquisition scintigraphy\n* Women of childbearing potential must have a negative serum or urine pregnancy test done within 7 days before randomization\n* Affiliated to the French Social Security System (or equivalent)\n* Patient willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n* Patient previously treated with any ADC targeting HER2 or TROP2\n* Patient with uncontrolled or significant cardiovascular disease\n* Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline\u002Fscreening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening\n* Any medical history or condition that per protocol or in the opinion of the investigator is incompatible with the study\n* Patients with known allergy or severe hypersensitivity to any of the trial drugs or their excipients\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may cause misleading study interpretation or prevent completion of study procedures and followup examinations\n* Patients with any other disease or illness that requires hospitalisation or is incompatible with the trial treatment are not eligible\n* Patients enrolled in another therapeutic trial within 30 days of inclusion\n* Pregnant or breast-feeding women at the time of randomization or intention to become pregnant during the study and up to 7 months after treatment\n* Person deprived of their liberty or under protective custody or guardianship\n* Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons",{"count":94,"type":19},260,[96],"PHASE2","This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer.\n\nThe goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?",[99,100,29],"Triple Negative Breast Neoplasms","Neoplasm Metastasis",[102,103,104,105,106,70],"Antibody-drug conjugates","HER2-low","Triple Negative Breast Cancer","Locally Advanced Breast Cancer","HER2-negative","2025-08-25",{"date":76,"type":48},{"date":110,"type":19},"2025-10",{"date":112,"type":19},"2029-10",{"name":114,"class":55},"UNICANCER",2,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":122,"minAge":16,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":125,"phases":4,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100553927","correlation-study-of-serum-her-2-against-her-2-adc-drug-efficacy-in-her-2-low-expressing-breast-cancer-100553927","NCT06492447","Correlation Study of Serum HER 2 Against HER 2-ADC Drug Efficacy in HER 2 Low-expressing Breast Cancer","Inclusion Criteria:\n\n* 1\\. Subjects with pathologically confirmed breast cancer; 2. The therapeutic drugs are anti-HER2-ADC drugs; 3. No history of other tumors; 4. Age \\> 18 years old; 5. Have relatively complete clinical case characteristics data.\n\nExclusion Criteria:\n\n* 1\\. Male breast cancer subjects; 2. Suffering from other malignant neoplasms; 3. Subjects with incomplete clinical case characteristics.","FEMALE",{"count":124,"type":19},50,"OBSERVATIONAL","Breast cancer is one of the most common malignancies in women worldwide, with HER2-positive breast cancer accounting for about 15-20% of all breast cancer cases. HER2 (Human epidermal growth factor receptor 2) is a tyrosine kinase receptor that, when overexpressed, promotes the growth and spread of tumor cells. The advent of anti-HER2 therapy, particularly antibody-coupled drugs (ADCs), has resulted in significant survival benefits for HER2-positive breast cancer subjects.\n\nAt present, the value of serum HER2 in the monitoring of anti-HER2-ADC drug therapy is insufficient. The purpose of this study was to investigate changes in serum HER2 expression levels in breast cancer subjects treated with anti-HER2-ADC drugs and the relationship between these changes and treatment effect. The therapeutic effect of HER2 was evaluated by continuous detection of HER2 serum, which provided a theoretical basis for the selection of clinical drug treatment.",[29],"2024-07-02",{"date":130,"type":48},"2024-07-09",{"date":132,"type":19},"2024-07-04",{"date":134,"type":19},"2026-03-04",{"name":136,"class":55},"Tianjin Medical University Cancer Institute and Hospital"]