[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643891":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":34,"responsibleParty":44,"collaborators":34,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":34,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":70,"whyStopped":34,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":34},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm-A","EXPERIMENTAL","SHRA1811 at 4.8 mg\u002Fkg in combination with BP102 at 15 mg\u002Fkg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle.",[13],"Drug: SHR-A1811+BEV",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm-B","ACTIVE_COMPARATOR","SHRA1811 at 4.8 mg\u002Fkg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle.",[19],"Drug: SHR- A1811",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","SHR- A1811","SHRA1811(HER-targeted ADC) 4.8 mg\u002Fkg, administered via intravenous infusion on Day 1 of each 3-week cycle.",[15],[27],"Trastuzumab Rezetecan",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"SHR-A1811+BEV","SHRA1811(HER-targeted ADC) at 4.8 mg\u002Fkg in combination with BEV(bevacizumab) at 15 mg\u002Fkg, administered by intravenous infusion on Day 1, with a 3-week treatment cycle.",[9],[33],"Trastuzumab Rezetecan；bevacizumab",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Zhimin Shao","CONTACT","02164175590","zhimingshao@yahoo.com",{"name":42,"role":38,"phone":39,"phoneExt":34,"email":43},"Yin Liu","liuyinfudan@163.com",{"type":45,"investigatorFullName":37,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Director of General Surgery of Fudan Shanghai Cancer Center","100643891","phase-3-an-open-label-randomized-phase-iii-study-of-trastuzumab-rezetecan-with-or-without-bevacizumab-in-first-to-third-line-blis-subtype-tnbc-100643891",false,"NCT07669610","An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab in First to Third Line BLIS Subtype TNBC","A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab as First- to Third-Line Treatment for Basal-like Immune-suppressed Triple-Negative Breast Cancer","TRIBE","Inclusion Criteria:\n\n1. Female patients aged ≥18 years and ≤70 years;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;\n3. Life expectancy of at least 3 months;\n4. Histologically confirmed invasive triple-negative breast cancer (defined as breast cancer with estrogen receptor \\[ER\\], progesterone receptor \\[PR\\], and human epidermal growth factor receptor 2 \\[HER-2\\] all determined to be negative by pathological testing. Specifically: ER-negative: IHC \\\u003C1%; PR-negative: IHC \\\u003C1%; HER2-negative: IHC -\u002F+ or IHC ++ with FISH\u002FCISH negative. All specimens must be verified as the BLIS subtype of the Fudan quadruple molecular classification by the Precision Medicine Center\u002FDepartment of Pathology at the study's participating center);\n5. Tumor stage: recurrent or metastatic breast cancer; for locally recurrent disease, radical surgical resection must be confirmed by the investigator to be not feasible. Number of prior lines of therapy in the advanced setting ≤2;\n6. Patients must have at least one lesion (measurable and\u002For non-measurable) that has not been previously irradiated, can be accurately assessed at baseline by CT\u002FMRI, and can be repeatedly evaluated according to RECIST 1.1;\n7. Adequate major organ function, meeting the following criteria:\n\n   Hematological parameters: hemoglobin (HB) ≥90 g\u002FL (without blood transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count (PLT) ≥75×10⁹\u002FL;Biochemical parameters: total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; in the presence of liver metastases, ALT and AST ≤5×ULN; serum creatinine (Cr) ≤1×ULN, and calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula);\n8. No prior radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks before study initiation, and recovery from acute toxicities of prior treatment (if surgery was performed, the wound must be completely healed); no peripheral neuropathy or only grade I peripheral neurotoxicity;\n9. Female subjects of childbearing potential must agree to use a medically accepted contraceptive method during the study treatment period and for at least 3 months after the last dose of study drug;\n10. Subjects must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria will be excluded from this study:\n\n  1. Known central nervous system (CNS) metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, contrast-enhanced CT or contrast-enhanced magnetic resonance imaging (MRI) must be performed within 28 days before the first dose to rule out CNS metastases;\n  2. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;\n  3. Persistent adverse events of Grade ≥1 resulting from prior treatment. Exceptions to this are alopecia or conditions that the investigator deems should not preclude enrollment. Such cases should be clearly documented in the investigator's notes;\n  4. Major surgery (excluding minor procedures such as placement of vascular access) within 3 weeks before the first cycle of study treatment;\n  5. Pregnant or lactating patients;\n  6. Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;\n  7. Presence of third-space fluid accumulation (e.g., massive pleural effusion or ascites) that cannot be controlled by drainage or other methods;\n  8. Participation in another anti-tumor drug clinical trial within 3 weeks before the first use of the study drug;\n  9. Long-term unhealed wounds or incompletely healed fractures;\n  10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or HBV DNA ≥500 IU\u002FmL, or chronic hepatitis with abnormal liver function;\n  11. History of allergic constitution, known allergy to any component of the study drug regimen, or history of allergy to other monoclonal antibodies;\n  12. History of gastrointestinal bleeding within the past 6 months, or clear evidence of a tendency for gastrointestinal bleeding, such as esophageal varices at risk of bleeding, active local ulcerative lesions, or fecal occult blood test ≥ (++). Patients with fecal occult blood test (+) should undergo gastroscopy;\n  13. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment;\n  14. Urinalysis showing urine protein ≥ (++), or confirmed 24-hour urine protein quantification \\>1.0 g;\n  15. Hypertension that cannot be controlled to within normal range with antihypertensive medication (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg);\n  16. Prior use of anti-angiogenic agents or prior exposure to an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as the payload","FEMALE","18 Years","70 Years",{"count":59,"type":60},140,"ESTIMATED","INTERVENTIONAL",[63],"PHASE3","This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the BLIS subtype. A total of 140 patients are planned to be enrolled.",[66,67],"Breast Cancer","Triple Negative Breast Cancer (TNBC)",[69],"triple negative breast cancer","NOT_YET_RECRUITING","2026-06-20",{"date":73,"type":74},"2026-06-25","ACTUAL",{"date":76,"type":60},"2026-10-01",{"date":78,"type":60},"2029-03-30",{"name":5,"class":6}]