[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-low-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-low-breast-cancer":269},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,59,89,112,135,165,195,220,242,317,342],{"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":31,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100622429","phase-1-a-study-of-mutant-selective-inhibitor-cgt6297-in-patients-with-advanced-solid-tumors-100622429",false,"NCT07383506","A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors","A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations","Inclusion Criteria:\n\n1. Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and\u002For tumor:\n\n   1. Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer\n   2. Phase 1b Cohort 2, participants must have HR-positive\u002FHER2-negative or HER2-low breast cancer (immunohistochemistry \\[IHC\\] and in-situ hybridization results must meet ASCO-College of American Pathology guidelines for breast cancer or criteria)\n   3. Phase 1b Cohort 3 will allow all solid tumors that do not meet criteria for Phase 1b Cohorts 1 or 2, including head and neck cancers, other gynecological cancers, colorectal cancers harboring PIK3CA mutations\n2. Meet prior treatment requirement of:\n\n   1. Phase 1a: previously treated with and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n   2. Phase 1b: previously treated with or considered not appropriate for SOC first-line treatment for their condition\n3. Have at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1\n5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits\n6. Resolution of acute toxicities from prior anticancer therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities (other than parameters specified in screening testing as outlined below), as determined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE) v5.0.\n7. Have an ejection fraction ≥50%\n\nExclusion Criteria:\n\n1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.\n2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug\n3. Treatment with radiotherapy ≤2 weeks before the first dose of study drug.\n4. Clinically significant cardiac disease\n5. Ongoing or planned long-term (≥4 consecutive weeks) treatment with glucocorticoid steroids at greater than physiologic dosing (defined as equivalent to \\>20 mg\u002Fday prednisone)\n6. Diagnosis of diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 (defined as fasting glucose ≥140 mg\u002FdL and HbA1c ≥7.0%; antihyperglycemic medical management permitted with the exception of insulin)\n7. Previous molecular testing (NGS or PCR) showed tumor with the following mutations: mutations\u002Fdeletions in PTEN or activating mutations in AKT, HRAS\u002FKRAS\u002FNRAS, EGFR, and BRAF","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA mutations",[26,27,28,29,30],"PIK3CA Mutations","Advanced Solid Tumors, Adult","Endometrial Cancer","HR Positive\u002FHER-2 Negative Breast Cancer","HER2-low Breast Cancer",[32,33,34,35,26,36,28,37,38,39,40,41,42,43,44,30,45],"HER2","PI3K","Mutant-Selective Inhibitor","Advanced solid tumors","PIK3CA SNVs","Breast Cancer","HR+\u002FHER2 Negative breast cancer","HR+\u002FHER2 (-) breast cancer","HR+\u002FHER2 low breast cancer","PI3KCA Genetic Alterations","PI3KCA Point Mutations","PI3KCA Gene Short Variants","PI3KCA active alteration","Phase 1a\u002F1b","RECRUITING","2026-06-30",{"date":49,"type":50},"2026-07-01","ACTUAL",{"date":52,"type":20},"2026-06",{"date":54,"type":20},"2029-08",{"name":56,"class":57},"Cogent Biosciences, Inc.","INDUSTRY",4,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":66,"minAge":17,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":72,"conditions":73,"keywords":74,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100627270","phase-2-disitamab-vedotin-plus-bevacizumab-in-her2-low-metastatic-breast-cancer-after-t-dxd-failure-a-phase-ii-study-100627270","NCT07446452","Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study","A Phase II Clinical Study to Evaluate the Efficacy and Safety of Disitamab Vedotin in Combination With Bevacizumab in Patients With HER2-Low Metastatic Breast Cancer After Progression on Prior T-DXd Therapy","Inclusion Criteria:\n\n1. Signed written informed consent prior to any study-related procedures.\n2. Female or male participants aged 18 years or older.\n3. Histologically or cytologically confirmed advanced or recurrent\u002Fmetastatic HER2-low breast cancer (IHC 1+ or IHC 2+\u002FISH-).\n4. Received at least two cycles of trastuzumab deruxtecan (T-DXd) during treatment for recurrent or metastatic disease.\n5. At least one measurable lesion according to RECIST version 1.1. A lesion within a previous radiation field may be considered measurable if disease progression is confirmed at that site.\n6. ECOG performance status 0-2.\n7. Expected survival time \\>3 months.\n8. Left ventricular ejection fraction (LVEF) ≥50% by ECHO or MUGA within 4 weeks prior to the first dose.\n9. Adequate organ function as determined by laboratory assessments per investigator's judgment.\n\nExclusion Criteria:\n\n1. Uncontrolled comorbid conditions.\n2. Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring drainage within 2 weeks prior to enrollment.\n3. History or current evidence of interstitial lung disease (ILD) or non-infectious pneumonitis.\n4. Use of systemic immunosuppressive medications within 14 days prior to the first dose.\n5. Clinically significant pulmonary comorbidities.\n6. Allogeneic organ transplantation or hematopoietic stem cell transplantation (except corneal transplant).\n7. Known hypersensitivity to bevacizumab, disitamab vedotin, or any of their components or excipients.\n8. Spinal cord compression or clinically active central nervous system (CNS) metastases.\n9. Unresolved toxicities or complications from prior therapy that have not recovered to baseline or ≤Grade 1 (per CTCAE v5.0).\n10. Known human immunodeficiency virus (HIV) infection (HIV-1\u002F2 antibody positive).\n11. Untreated active hepatitis B infection.\n12. Active hepatitis C virus (HCV) infection.\n13. Receipt of a live vaccine within 30 days before Cycle 1 Day 1.\n14. Pregnant or breastfeeding women.\n15. Any severe or uncontrolled systemic disease judged by the investigator to interfere with study participation or safety evaluation.\n16. Gastrointestinal perforation or fistula, wound dehiscence requiring medical intervention, wound-healing complications, severe hemorrhage, arterial thrombotic events, or life-threatening (Grade 4) venous thromboembolism, including pulmonary embolism.","FEMALE","75 Years",{"count":69,"type":20},37,[71],"PHASE2","This is a multicenter, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of disitamab vedotin in combination with bevacizumab in patients with HER2-low advanced or metastatic breast cancer who have experienced disease progression following prior T-DXd therapy. Eligible patients must have HER2-low expression (IHC 1+ or 2+\u002FFISH-) and have previously received T-DXd. Participants will receive RC48 (disitamab vedotin) plus bevacizumab according to the study protocol.\n\nTreatment-related adverse events will be closely monitored and managed, with severity graded according to CTCAE v5.0 criteria. Supportive care or dose adjustments will be implemented as necessary. The primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR), all of which will be evaluated by an independent review committee. Safety assessments will include the incidence, severity, management, and outcomes of adverse events. Patient-reported quality of life will be evaluated using the EORTC QLQ-C30 questionnaire at predefined intervals.\n\nIn addition, this study will conduct exploratory multi-omics translational research to investigate the potential molecular mechanisms underlying treatment response and resistance, and to identify predictive biomarkers associated with clinical outcomes. The ultimate goal is to assess the therapeutic efficacy and safety of this regimen, and to develop predictive models that may help identify HER2-low patients most likely to benefit, thereby supporting precision and individualized treatment strategies.",[30],[75,76,77],"Disitamab Vedotin (RC48)","Bevacizumab","Trastuzumab deruxtecan failure","2026-02-28",{"date":80,"type":50},"2026-03-03",{"date":82,"type":50},"2024-01-01",{"date":84,"type":20},"2027-01-01",{"name":86,"class":87},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":66,"minAge":17,"maxAge":67,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100589705","phase-3-a-study-of-bl-m07d1-versus-investigators-choice-of-chemotherapy-in-patients-with-her2-low-recurrentmetastatic-breast-cancer-100589705","NCT06957886","A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent\u002FMetastatic Breast Cancer","A Randomized, Controlled Phase III Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent\u002FMetastatic Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent and follow the requirements of the protocol;\n2. Women aged ≥18 years and ≤75 years at the time of written informed consent;\n3. Expected survival time ≥12 weeks;\n4. Histologically or cytologically confirmed unresectable, locally recurrent or metastatic HER2-low breast cancer;\n5. Provide the latest tumor tissues to the central laboratory for HER2 and HR detection;\n6. Meet the treatment requirements in the plan;\n7. Must have at least one measurable target lesion that meets the RECIST v1.1 definition;\n8. ECOG 0 or 1;\n9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;\n10. Organ function level must meet the requirements;\n11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All enrolled patients (male or female) should use adequate, highly effective contraception for the entire treatment cycle and for 7 months after completion of treatment.\n\nExclusion Criteria:\n\n1. Received mitomycin C and nitrosourea chemotherapy within 6 weeks before the first dose, and received surgery or radical radiotherapy within 4 weeks before the first dose;\n2. Patients who were not suitable to use the control drugs chosen by the researchers because of intolerance to the chemotherapy drugs of the control group or other contraindications;\n3. Previous treatment with anti-HER2 drugs;\n4. Prior ADC drug therapy with camptothecin derivative as toxin;\n5. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;\n6. Severe impairment of lung function due to concurrent pulmonary diseases;\n7. History of ILD\u002Finterstitial pneumonia requiring steroid therapy, current ILD\u002Finterstitial pneumonia or suspected ILD\u002Finterstitial pneumonia;\n8. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n9. Other primary malignancies diagnosed within 5 years before the first dose;\n10. Poorly controlled hypertension;\n11. Patients with active central nervous system metastases;\n12. Patients with a history of severe allergy to any excipients or components of the study drug;\n13. History of autologous or allogeneic stem cell transplantation or organ transplantation;\n14. Anthracycline-equivalent cumulative dose of adriamycin \\> 360 mg\u002Fm2;\n15. Human immunodeficiency virus antibody positive, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection;\n16. Serious infection within 4 weeks before the first dose of study drug; Severe infection requiring antibiotic, antiviral or antifungal control at screening;\n17. Patients with massive effusions, or effusions with obvious symptoms, or poorly controlled effusions;\n18. Carcinomatous lymphangitis;\n19. Was receiving \\&gt before randomization; 10mg\u002Fd prednisone systemic corticosteroids or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy;\n20. The presence of a severe neurological or mental illness;\n21. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;\n22. Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea;\n23. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;\n24. Patients with other serious physical or laboratory abnormalities or poor compliance that may increase the risk of participating in the study or interfere with the results of the study, and patients who are considered by the investigators to be unsuitable for participating in the study.",{"count":97,"type":20},566,[99],"PHASE3","This trial is a registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.",[30],"2026-01-19",{"date":104,"type":50},"2026-01-21",{"date":106,"type":50},"2025-05-15",{"date":108,"type":20},"2027-12",{"name":110,"class":57},"Sichuan Baili Pharmaceutical Co., Ltd.",2,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":88},"100620481","efficacy-and-safety-of-trastuzumab-rezetecan-in-her2-expressing-breast-cancer-100620481","NCT07358182","Efficacy and Safety of Trastuzumab-rezetecan in HER2-Expressing Breast Cancer","Efficacy and Safety of Trastuzumab-rezetecan in HER2-Positive and HER2-Low Breast Cancer: A Multicenter, Observational, Real-World Study Protocol","Inclusion Criteria:\n\n1. Age ≥ 18 years, with pathologically confirmed HER2-positive or HER2-low-expressing breast cancer: HER2-positive is defined as IHC 3+ or IHC 2+ with a positive ISH result; HER2-low-expressing is defined as IHC 1+ or IHC 2+ with a negative ISH result for HER2 amplification; hormone receptor status must be clearly documented.\n2. Planned to receive treatment with Trastuzumab-rezetecan for Injection in the neoadjuvant, adjuvant, or advanced\u002Fmetastatic setting; patients with advanced\u002Fmetastatic disease must have progressed after at least one prior line of systemic therapy.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n4. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to enrollment, and both male and female patients must be willing to use a highly effective, medically approved method of contraception during the study and for 1 year after the last dose of the study drug.\n5. Non-pregnant and non-lactating female patients.\n6. Not concurrently participating in any other ongoing clinical studies. The patient or their legal representative has provided informed consent by signing the informed consent form and is willing and able to comply with scheduled visits, the study treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding disorders, active infections (such as hepatitis B, hepatitis C, and human immunodeficiency virus), or severely impaired bone marrow reserve or organ function (including hepatic and renal impairment), which, in the investigator's opinion, would significantly alter the risk-benefit balance.\n2. At the initiation of treatment with Trastuzumab-rezetecan for Injection, the patient has not recovered from any prior treatment-related toxicity of CTCAE grade \\>3.\n3. Known history of hypersensitivity to Trastuzumab-rezetecan for Injection, its excipients, or drugs with similar chemical structures or classes as Trastuzumab-rezetecan.\n4. Patients deemed unsuitable for enrollment by the investigator.",{"count":120,"type":20},300,"OBSERVATIONAL","This study is a multicenter, observational, real-world investigation. The research plans to enroll 300 HER2-positive and HER2-low breast cancer patients who meet the inclusion criteria. All patients included in the analysis are currently receiving or are scheduled to receive a treatment regimen containing Trastuzumab-rezetecan. There are no restrictions on the treatment regimen, which is entirely based on the clinician's choice. The study aims to evaluate the efficacy and safety of the treatment regimen containing Trastuzumab-rezetecan.\n\nAfter completing screening examinations and assessments, eligible patients will enter the study treatment phase. They will receive the treatment regimen containing Trastuzumab-rezetecan and undergo follow-up visits according to the protocol. During the study treatment period, patients will undergo imaging and safety assessments as per clinical routine, with the investigator's assessment serving as the final result. Upon treatment completion or study withdrawal, corresponding safety examinations and imaging assessment data will be collected. For neoadjuvant patients, pathological complete response (pCR) will be assessed post-surgery by pathologists at the participating centers.",[124,30,125],"Trastuzumab-rezetecan","HER2-positive Breast Cancer","2026-01-14",{"date":128,"type":50},"2026-01-22",{"date":130,"type":50},"2025-06-01",{"date":132,"type":20},"2031-06-30",{"name":134,"class":87},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100532282","a-study-to-assess-the-effectiveness-of-trastuzumab-deruxtecan-in-chinese-breast-cancer-patients-refresh-100532282","NCT06210776","A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)","A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)","Patients must meet all of the following inclusion criteria to be eligible for the study:\n\n1. ≥18 years of age at time of consent.\n2. Pathologically documented breast cancer that is unresectable or metastatic.\n3. Cohort A: Patients with confirmed HER2+ (IHC 3+ or IHC2+, ISH+); and patients have received one or more prior anti-HER2-based regimens; and patients should have received no more than 2 lines therapy in the metastatic settings.\n\n   Cohort B: Patients with confirmed HER2-low expression (IHC 1+ or IHC 2+, ISH-); and patients have received at least a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; and patients should have received no more than 2 lines of previous chemotherapy regimen in the metastatic settings.\n4. Decision to newly initiate T-DXd or just have started the first dose no longer than 14 days after the index date per approved label in China.\n5. Capable of providing informed consent.\n6. Patients capable of completing questionnaires are preferred. If the participant is unable to complete the questionnaire (e.g., being blind, illiterate, not fluent in the available language, or ePRO system is not ready), that participant is exempted from completing PRO questionnaires but may still participate in the study.\n\nPatients who meet any of the following criteria will be excluded from the study:\n\n1. Pregnancy or breastfeeding.\n2. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.\n3. Patients who have known to have hypersensitivity reactions to the active substance of T-DXd or any excipients.\n4. Patients who have been judged by the investigator to be unfit to participate the study.",{"count":143,"type":20},800,"This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens or patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+, ISH-) breast cancer who have received at least a prior systemic therapy in the metastatic setting, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.",[125,30,37,146],"Advanced Cancer",[148,149,150,151,152,153,154],"HER2-positive breast cancer","HER2-low breast cancer","Breast cancer","Advanced cancer","Unresectable or metastatic breast cancer","Trastuzumab deruxtecan","T-DXd","2026-01-09",{"date":157,"type":50},"2026-01-12",{"date":159,"type":50},"2024-01-15",{"date":161,"type":20},"2028-03-01",{"name":163,"class":57},"Daiichi Sankyo",54,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":66,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":88},"100579906","her2-pet-as-a-precision-imaging-tool-for-treatment-with-her2-adc-in-her2-expressing-mbc-100579906","NCT06830382","HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC","A Multicentre, Prospective, Open-label Study With [68Ga]Ga-ABY-025 PET-imaging to Characterize HER2-expression and Explore the Therapy-predictive Value for HER2-antibody Drug Conjugates in Patients With Metastatic Breast Cancer","Inclusion Criteria:\n\n* Female patients age ≥18 years.\n* Metastatic or locally advanced breast cancer with disease progression after ≥ 1 line of chemotherapy in the palliative setting, or with disease relapse within six months after completion of (neo-) adjuvant chemotherapy.\n* The patient must be able and willing to provide written consent to participate in the study.\n* At least one metastatic lesion ≥ 10 mm is available for biopsy\n\n  o Exception can be made when a recent biopsy is available (no more than 12 months old and without exposition to HER2-targeted therapy or local radiotherapy to the specific lesion).\n* At least one additional metastatic index lesion ≥ 10 mm for evaluation of treatment effect (according to RECIST v1.1)\n* WHO performance status ≤ 2.\n* Expected survival \\> 12 weeks.\n* Contraceptives: Females of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of the study treatment phase and for six months after the last dose of \\[68Ga\\]Ga-ABY-025. Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and\u002For surgically sterile), she must have a documented negative serum Pregnancy testing prior to each administration of the IMP is obligatory.\n\nExclusion Criteria:\n\n* Contra-indications for treatment for trastuzumab deruxtecan and inability to undergo this treatment as per local treatment routines.\n* A previously documented metastatic tumor biopsy that was HER2-positive (IHC 3+ and\u002For HER2 gene amplification).\n* Other manifest malignancies except for basal cell carcinoma of the skin.\n* Inadequate cardiac, renal, bone marrow or liver function\n* Patients with increased risk of complications from biopsies, i.e. increased risk of bleeding, defined as\n\n  * prothrombin time test (INR value) \\>1.4, platelet count \\\u003C70 (109\u002Fl), activated partial thromboplastin time (APTT) \\>30s.\n  * known bleeding disorders such as haemophilia, von Willebrand disease or platelet disorders.\n  * any anticoagulants or antiplatelet treatment that cannot be temporarily paused",{"count":173,"type":20},70,"This is a prospective, multi-center, open-label, exploratory diagnostic phase II imaging trial for patients with metastatic breast cancer with at least one line of systemic therapy.\n\nThe overarching aim of the HER2-Ex PET trial is to study the role of precision imaging utilizing positron emission tomography (PET) with the HER2-specific tracer \\[68Ga\\]Ga-ABY-025 (hereafter referred to as HER2-PET) in enhancing treatment planning for patients with metastatic HER2-expressing breast cancer Patients will be allocated based on HER2-status on PET and biopsy. Patients with HER2-expressing lesions in a fresh or archived tumour biopsy will be treated with T-DXd.\n\nThe study hypothesis is that PET\u002FCT precision imaging with a contemporary HER2-radiotracer (\\[68Ga\\]Ga-ABY-025) can be used and can lead to a potentially better identification of patients who benefit from T-DXd treatment, thereby achieving improved treatment responses as well as fewer side effects. This study's diagnostic approach provides a more individualized treatment strategy. Additionally, this study can potentially give us a better biological understanding of HER2-expressing mBC.",[176,30,177],"Breast Cancer Stage IV","Molecular Imaging",[179,180,181,182,183,184,185],"HER2-PET","molecular imaging","precision imaging","HER2-low mBC","metastatic breast cancer","HER2-ADC","ABY-025","2025-11-17",{"date":188,"type":50},"2025-11-20",{"date":190,"type":50},"2025-10-03",{"date":192,"type":20},"2032-04-01",{"name":194,"class":87},"Renske Altena",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":210,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":5},"100557108","phase-2-treatment-of-adc-refractory-breast-cancer-with-dato-dxd-or-t-dxd-trade-dxd-100557108","NCT06533826","TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd","A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-negative (HER2-low or HER2-0) Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy","TRADE DXd","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation; i.e., visible chest wall disease or metastases on imaging meeting standard radiology criteria (i.e., lymph nodes larger than 1 cm in the short axis diameter).\n* The most recent pathology results will be considered for enrollment according to local testing of ER, PR and HER2 in a CLIA-certified environment. ER, PR and HER2 status per local testing must be known prior to study registration.\n* Participants must have history of HER2-low or HER2-0 breast cancer per local testing, and no known history of HER2-positive breast cancer. All available prior HER2 pathology results must be HER2-low or HER2-0; no known HER2 IHC 3+ or ISH-amplified breast cancer is allowed.\n\n  * HER2-low status is defined as IHC 1+ or 2+\u002FISH non-amplified breast cancer in any prior tumor sample (e.g., primary or metastatic tumor) collected prior to study enrollment: IHC 2+\u002FISH-, IHC 1+\u002FISH-, or IHC 1+\u002FISH untested (note: ISH may be determined by either fluorescence in situ hybridization \\[FISH\\] or dual in situ hybridization \\[DISH\\])\n  * HER2-0 status is defined as IHC 0 (null or ultra-low) in all prior tumor samples with available HER2 pathology results: IHC 0+\u002FISH- or IHC 0+\u002FISH untested (IHC 0+: IHC 0 absent membrane staining \\[null\\] or IHC 0 with membrane staining \\>0 and \\\u003C1+ \\[ultralow\\]). Note: Enrollment of patients with HER2-0 breast cancer will be capped at 15% in each ADC1 and ADC2 cohort.\n* Participants with any HR status will be allowed on study.\n\n  * HR-positive cohorts: ER and\u002For PR expression ≥1%\n  * HR-negative cohorts: ER and PR expression \\\u003C1%\n  * All cohorts: The most recent HER2 pathology result must be HER2-0 or HER2-low (i.e., must not be HER2-positive).\n  * HER2-0: IHC 0+\u002FISH- or IHC 0+\u002FISH untested.\n  * HER2-low: IHC 2+\u002FISH-, IHC 1+\u002FISH-, or IHC 1+\u002FISH untested (note: ISH may be determined by either fluorescence in situ hybridization \\[FISH\\] or dual in situ hybridization \\[DISH\\]).\n* Participants must have measurable disease per RECIST 1.1.\n* Participants must be willing to undergo research tissue biopsies (at baseline prior to ADC1, after 3 weeks of treatment with ADC1, at progression on ADC1 or baseline prior to ADC2, and at progression on ADC2), if tumor is safely accessible.\n* Prior endocrine therapy: Participants with HR-positive breast cancer considered to be candidates for endocrine therapy must have: a) progressed on or within 12 months of adjuvant endocrine therapy or received at least one line of endocrine therapy in the metastatic setting, and b) received prior CDK4\u002F6 inhibitor. Prior endocrine therapy does not require washout.\n* Prior chemotherapy: Prior lines of chemotherapy allowed in the metastatic setting are specified below. Prior topoisomerase I inhibitor therapy is not allowed in any setting, except as specified below for ADC2 cohorts. Participants may have discontinued all chemotherapy at least 14 days prior to study treatment initiation. All toxicities related to prior chemotherapy must have resolved to CTCAE v5.0 grade 1 or lower, unless otherwise specified per protocol, except alopecia (any grade allowed) and neuropathy (grade 2 or lower allowed).\n\n  * ADC1 T-DXd cohorts: Participants must have progressed on 0-1 prior lines in the metastatic setting.\n  * ADC1 Dato-DXd cohorts: Participants must have progressed on 0-1 prior lines in the metastatic setting.\n  * ADC2 T-DXd cohorts: Participants must have progressed on 1-2 prior lines in the metastatic setting, including Dato-DXd (single-agent) as the most recent therapy. Confirmation of documented progressive disease on Dato-DXd (single-agent) as the most recent therapy is required prior to enrollment. No other topoisomerase I inhibitor is allowed in the metastatic setting.\n  * ADC2 Dato-DXd cohorts: Participants must have progressed on 1-2 prior lines in the metastatic setting, including T-DXd (single-agent) as the most recent therapy. Confirmation of documented progressive disease on T-DXd (single-agent) as the most recent therapy is required prior to enrollment. No other topoisomerase I inhibitor is allowed in the metastatic setting.\n* Prior biologic or targeted therapy: Patients must have discontinued all biologic or targeted therapy (e.g., CDK4\u002F6 inhibitor) at least 14 days prior to study treatment initiation. All toxicities related to prior biologic or targeted therapy must have resolved to CTCAE v5.0 grade 1 or lower, unless otherwise specified per protocol.\n* Prior investigational agents for treatment of cancer: Investigational agents must have been discontinued at least 21 days prior to initiation of study therapy. All toxicities related to prior investigational agents must have resolved to CTCAE v5.0 grade 1 or lower, unless otherwise specified per protocol.\n* Prior radiation therapy: Patients may have received prior radiation therapy. Radiation therapy must be completed at least 14 days prior to the initiation of study treatment (at least 7 days for SRS), and all toxicities related to prior radiation therapy must have resolved to CTCAE v5.0 grade 1 or lower, unless otherwise specified per protocol. A 7-day washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.\n* Patients with history of treated CNS metastases are eligible, provided the following criteria are met:\n\n  * Disease outside the CNS is present.\n  * Prior SRS\u002FSRT or WBRT should be completed ≥ 7 days before study treatment initiation.\n  * Recovery from acute toxicity associated with the treatment to ≤ CTCAE v5.0 grade 1 or baseline (with the exception of alopecia), with no requirement for escalating doses of corticosteroids over the past 7 days.\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy, there is no requirement for corticosteroids, and the patient is asymptomatic.\n* Participants on bisphosphonates or RANK ligand inhibitors may continue receiving therapy during study treatment and also may initiate therapy with these agents on study if clinically indicated.\n* The subject is ≥ 18 years old.\n* ECOG performance status 0-1 (Karnofsky \\> 60%).\n* Participants must have adequate organ and marrow function within 2 weeks prior to study treatment initiation as defined below:\n\n  * Absolute neutrophil count ≥1,500\u002FmcL\n  * Platelets ≥ 100,000\u002FmcL\n  * Hemoglobin ≥ 9.0 g\u002Fdl\n  * INR\u002FPT\u002FaPTT ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy and PT or aPTT is in therapeutic range of anticoagulant\n  * Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (or ≤ 3.0 x ULN in patients with documented Gilbert's Syndrome)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional ULN or ≤ 5.0 × institutional ULN for participants with documented liver metastases\n  * Serum or plasma creatinine ≤ 1.5 × institutional ULN OR creatinine clearance (as calculated using the Cockcroft-Gault equation) ≥ 30 mL\u002Fmin\u002F 1.73m2 for participants with creatinine levels above institutional ULN.\n* Resolution of all toxicities related to prior anticancer therapy to Grade ≤ 1 or baseline, including toxicities from ADC1 before enrolling to ADC2, unless otherwise specified per protocol.\n* For T-DXd cohorts, baseline LVEF ≥ 50% prior to registration, as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive).\n* Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to study treatment initiation. Childbearing potential is defined as participants who have not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n* Women of childbearing potential (WOCBP) and the female partners of male participants must agree to use an adequate method of contraception. Contraception is required starting with the first dose of study medication through 7 months after the last dose of study medication.\n* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment and 4 months after the last dose of study treatment.\n* The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Concurrent use of any other investigational or study agents that are being used to treat the underlying malignancy.\n* Any prior treatment (including ADC) containing a chemotherapeutic agent targeting topoisomerase I, except as specified per protocol for ADC2 cohorts.\n* Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention.\n* Clinically significant corneal disease.\n* History of severe hypersensitivity reactions to either trastuzumab deruxtecan or datopotamab deruxtecan or their inactive ingredients.\n* History of severe hypersensitivity reactions to other monoclonal antibodies.\n* Major surgery within 2 weeks prior to study treatment initiation.\n* Uncontrolled, significant intercurrent or recent illness including, but not limited to, ongoing or active infection, uncontrolled non-malignant systemic disease, uncontrolled seizures, or psychiatric illness\u002Fsocial situation that would limit compliance with study requirements in the opinion of the treating investigator.\n* History of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or current pneumonitis\u002Finterstitial lung disease, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening. For ADC2 cohorts, if a participant experienced G1 pneumonitis\u002FILD with ADC1 (e.g., treated with steroids) with complete resolution of radiographic findings and ability to resume ADC1 within 12 weeks of the scheduled interruption without recurrence of ILD, the participant may enroll to ADC2.\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and prior complete pneumonectomy.\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\>450 msec (males).\n* Any of the following procedures or conditions in 6 months prior to enrollment: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure (New York Heart Association Functional Classification Grade ≥2), and stroke.\n* Individuals with a history of a second malignancy are ineligible except for the following circumstances:\n\n  * Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy.\n  * Individuals with the following cancers that have been diagnosed and treated within the past 3 years are eligible: cervical\u002Fprostate carcinoma in situ, superficial bladder cancer, non-melanoma cancer of the skin.\n  * Patients with other cancers diagnosed within the past 3 years and felt to be at low risk of recurrence should be discussed with the study principal investigator to determine eligibility.\n* Known human immunodeficiency virus (HIV) infection that is not well controlled.\n* Known hepatitis B or C virus infection that is active or uncontrolled.\n* Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice).\n* 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* Women who are pregnant or breastfeeding or planning to become pregnant.",{"count":204,"type":20},357,[71],"The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-negative (HER2-low or HER2-0) metastatic breast cancer.\n\nThe names of the study drugs involved in this study are:\n\n* Datopotamab deruxtecan (a type of antibody drug conjugate)\n* Trastuzumab deruxtecan (a type of antibody drug conjugate)",[37,30,208,209],"Metastatic Breast Cancer","HER2-negative Breast Cancer",[37,30,208,209],"2025-10-23",{"date":213,"type":50},"2025-10-24",{"date":215,"type":50},"2024-10-29",{"date":217,"type":20},"2038-08-01",{"name":219,"class":87},"Ana C Garrido-Castro, MD",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":66,"minAge":17,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":88},"100475121","distribution-of-the-homologous-recombination-related-hrr-genesmutationsand-hrd-in-breast-cancer-100475121","NCT05466786","Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer","Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance","Inclusion Criteria:\n\n1. Female patients aged 18-70 years with pathologically confirmed HER2-low breast cancer (defined as IHC 2+\u002FISH- or IHC 1+ per ASCO\u002FCAP guidelines);\n2. ECOG performance status of 0 or 1;\n3. Treatment-naïve operable primary breast cancer with completed homologous recombination deficiency (HRD) assessment;\n\n5）Absence of distant metastasis; 6）Availability of adequate tumor tissue and blood samples for biomarker analysis.\n\nExclusion Criteria:\n\n1. Recurrent or inoperable locally advanced breast cancer;\n2. Bilateral breast cancer;\n3. History of other malignant tumors within the past 5 years;\n4. Incomplete clinical or pathological data.","70 Years",{"count":229,"type":20},255,"This is a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 255 subjects with HRD (homologous recombination deficiency) assessment will be enrolled in this study to examine the distribution and features of HRD\u002FHRR (homologous recombination repair).\n\nIn this study, investigators plan to clarify the frequency of HRR\u002FHRD in Chinese patients with HER2-low breast cancer.\n\nIn addition, it is planned to investigate any association between invasive disease-free survival (iDFS)\u002Foverall survival (OS) and HRD\u002FHRR in HER2-low breast cancer patients.",[37,30],[233,234],"Homologous recombination-related","Homologous recombination deficiency","2025-09-29",{"date":190,"type":50},{"date":238,"type":50},"2022-08-07",{"date":240,"type":20},"2027-05-31",{"name":134,"class":87},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":252,"briefSummary":253,"conditions":254,"keywords":273,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":316},"100505964","phase-1-pre-i-spy-phase-iib-oncology-platform-program-100505964","NCT05868226","PRE-I-SPY Phase I\u002FIb Oncology Platform Program","PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I\u002FIb Platform Trial","PRE-I-SPY-PI","General Inclusion Criteria (GIC):\n\n* GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable).\n* GIC2: Age ≥ 18 years at the time of signing the informed consent\n* GIC3: Gender: Male or female (premenopausal and postmenopausal)\n* GIC4: ECOG performance status Grade 0-2\n* GIC5: Estimated life expectancy \\> 12 weeks at the start of investigational medicinal product (IMP) treatment.\n* GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL\u002Fmin for small molecules and \\>30 mL\u002Fmin for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility.\n\nThese cut-off values may be modified with supporting data for specific drug regimens.\n\n* GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment.\n* GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom \u002F occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository).\n* GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.\n* GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Additional arm specific inclusion criteria as needed by drug arm regimen\n\nGeneral Exclusion Criteria (GEC):\n\n* GEC1: Wash out periods: No other anticancer therapy within the following periods:\n\n  * chemotherapy or investigational agents, 3 weeks\n  * mitomycin C and nitrosoureas, 6 weeks\n  * radiotherapy, 3 weeks\n  * targeted therapy, 2 weeks\n  * MAbs, ADCs, and immunotherapy, 3 weeks\n  * endocrine therapy, no washout needed\n* GEC2: Concurrent therapy with other Investigational Products.\n* GEC3: Prior history of drug\u002Fregimen hypersensitivity: History of infusion-related reactions and\u002For hypersensitivity to IMP or excipients of the study drug\u002Fdrugs which led to permanent discontinuation of the treatment.\n* GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length \\> 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens.\n* GEC6: CNS tumoral spread: Active uncontrolled\u002Fsymptomatic central nervous system cancer\u002Fspinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be permitted.\n* GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.\n* GEC8: Recent major surgery within 4 weeks prior to start IMP treatment\n* GEC9: Pregnancy or breastfeeding\n* GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n* GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial.\n* Additional arm specific exclusion criteria as needed by drug arm regimen",{"count":251,"type":20},124,[23],"I-SPY Phase I\u002FIb (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and\u002For other oncology-based trials in a timely manner.",[125,255,208,256,257,258,259,209,260,261,262,263,264,265,266,267,268,269,270,271,272],"Metastatic Cancer","Metastatic","HER2-positive Metastatic Breast Cancer","HER2 Mutation-Related Tumors","HER-2 Protein Overexpression","Triple Negative Breast Cancer","HR Positive","Hormone Receptor-positive Breast Cancer","Estrogen Receptor Positive Tumor","Progesterone Receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma","Solid Tumor","Solid Tumor, Adult","Solid Carcinoma","HER2 Low Breast Cancer","HER2 Low Breast Carcinoma","ER Positive Breast Cancer","PR-positive Breast Cancer",[274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,154,300,301,302,303,304,305,306],"I-SPY Trials","Quantum Leap Healthcare Collaborative","QLHC","I-SPY","I-SPY2","I-SPY1","PRE-ISPY","PRE-I-SPY","I-SPY Phase 1","I-SPY Phase 1b","I-SPY-P1","ISPY","ISPYP1","I-SPY Phase 1 Platform","ISPY2","ISPY1","Phase 1 Platform","Phase 1 Oncology Platform","T-DXd naive","PRE1","PRE2","PRE3","PRE","PRE-I-SPY Phase 1","PRE-I-SPY Phase 1b","ALX148","Enhertu","Zanidatamab","Tucatinib","Ziihera","Tukysa","Evorpacept","QL","2025-04-01",{"date":309,"type":50},"2025-04-04",{"date":311,"type":50},"2023-02-15",{"date":313,"type":20},"2029-12-30",{"name":315,"class":87},"QuantumLeap Healthcare Collaborative",7,{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":326,"conditions":327,"keywords":330,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":88},"100583522","analysis-of-exploring-optimized-sequential-treatment-strategies-of-antibody-drug-conjugates-adcs-in-her2-low-expressing-breast-cancer-100583522","NCT06877416","Analysis of Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer","A Multi-center, Retrospective, Study on Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer","Inclusion Criteria:\n\n* Diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative)\n* Received sequential administration of two or more ADCs\n* Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.\n\nExclusion Criteria:\n\n* Concomitant with other tumor components at the time of diagnosis;\n* Have a history of any other malignant tumors;\n* Lack of complete data",{"count":325,"type":20},700,"This study retrospectively analyzes the clinical data of HER2-low breast cancer (IHC 1+\u002F2+ and FISH-negative) patients treated with sequential antibody-drug conjugates (ADCs). Key variables include patient demographics, tumor characteristics, ADC regimens (e.g., trastuzumab deruxtecan, sacituzumab govitecan), treatment sequencing, survival outcomes, and safety profiles. Genomic data (e.g., HER2 expression dynamics, TROP2 levels) are integrated to explore resistance mechanisms and prognostic biomarkers.mechanisms.\n\nThis study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients.",[328,30,329],"Antibody-drug Conjugates","Breast Neoplasms",[331,30,332],"Antibody-drug conjugates","Retrospective Studies","2025-03-17",{"date":335,"type":50},"2025-03-20",{"date":337,"type":50},"2020-01-01",{"date":339,"type":20},"2026-01",{"name":341,"class":87},"Sun Yat-sen University",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":66,"minAge":17,"maxAge":227,"enrollmentInfo":349,"targetDuration":4,"studyType":21,"phases":351,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":359,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":4},"100572435","phase-2-a-study-evaluating-the-efficacy-and-safety-of-de-trastuzumab-t-dxd-in-combination-with-immunotherapy-for-the-neoadjuvant-treatment-of-hr-positive-her2-low-expressing-chinese-patients-with-early-stage-breast-cancer-100572435","NCT06733233","A Study Evaluating the Efficacy and Safety of De Trastuzumab (T-DXd) in Combination with Immunotherapy for the Neoadjuvant Treatment of HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer","A Multicenter, Prospective Phase II Single-arm Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment with T-DXd in Combination with an Immune Checkpoint Inhibitor in HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer","Inclusion Criteria:\n\n1. Adults between the ages of 18 and 70 at the time of signing the informed consent form.\n2. An Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.\n3. Previously untreated, operable invasive breast cancer measuring greater than 2.0 centimeters (cT2) with positive clinical lymph nodes (cN1\u002FcN2); or clinically staged T3-T4, clinically lymph node-negative (N0) or clinically lymph node-positive (cN1\u002FcN2) without distal metastases.\n4. Tumors with low levels of HER2 expression by immunohistochemistry (IHC), defined as IHC 1+ or IHC 2+ and FISH negative.\n5. Tumor documented as HR-positive (ER and\u002For PgR-positive \\[ER or PgR ≥1%\\] by local assessment according to ASCO-CAP guidelines).\n6. Patients who agree to undergo surgical treatment for breast cancer when they meet surgical criteria after neoadjuvant therapy.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer and bilateral breast cancer\n2. Previous history of invasive breast cancer.\n3. Previous history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)\n4. Other malignant tumors within 5 years, excluding cured carcinoma in situ of the cervix and non-melanoma skin cancers.",{"count":350,"type":20},23,[71],"This is a prospective, open-label, multicenter, single-arm clinical study designed to compare the efficacy and safety of neoadjuvant treatment with T-DXd in combination with an immune checkpoint inhibitor in patients with primary intermediate- to high-risk HR-positive, HER2-overexpressing early-stage breast cancer.",[354,269],"Breast Cancer, Estrogen Receptor-Positive",[150,356,357,358],"immunotherapy","DS8201","Neoadjuvant","NOT_YET_RECRUITING","2024-12-10",{"date":362,"type":50},"2024-12-13",{"date":364,"type":20},"2025-01-01",{"date":366,"type":20},"2029-01-01",{"name":368,"class":87},"Guangzhou Women and Children's Medical Center"]