[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637248":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":26,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":26,"overallStatus":74,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (Sac-TMT)","EXPERIMENTAL","Sacituzumab Tirumotecan (sac-TMT) is administered intravenously at a dose of 4 mg\u002Fkg on Day 1 of each 3-week cycle for a total of 8 cycles. Following completion of the 8 cycles, sequential capecitabine therapy may be administered at the investigator's discretion, with stratified dosing regimens as follows: for patients who received neoadjuvant therapy, capecitabine is given orally at 1000-1250 mg\u002Fm² twice daily, on a 2-week on\u002F1-week off schedule for 6-8 cycles; for patients without prior neoadjuvant therapy, capecitabine is given orally at 650 mg\u002Fm² twice daily for 1 year. Patients who received PD-1\u002FL1 inhibitor therapy during the neoadjuvant phase shall continue PD-1\u002FL1 inhibitor treatment for up to 1 year in total.",[13],"Drug: Sacituzumab Tirumotecan (sac-TMT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B (capecitabine)","ACTIVE_COMPARATOR","Capecitabine is administered orally with stratified doses based on prior neoadjuvant therapy status: for patients who received neoadjuvant therapy, capecitabine is given at 1000-1250 mg\u002Fm² twice daily on a 2-week-on-1-week-off schedule for 6-8 cycles; for patients without prior neoadjuvant therapy, capecitabine is given at 650 mg\u002Fm² twice daily for 1 year.\n\nPatients who received PD-1\u002FL1 inhibitor therapy during the neoadjuvant phase shall continue PD-1\u002FL1 inhibitor treatment until completion of 1-year total duration.",[19],"Drug: Capecitabine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sacituzumab Tirumotecan (sac-TMT)","Sacituzumab Tirumotecan (sac-TMT) is administered intravenously at a dose of 4 mg\u002Fkg on Day 1 of each 3-week cycle for a total of 8 cycles.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Capecitabine","Capecitabine is administered orally with stratified doses based on prior neoadjuvant therapy status: for patients who received neoadjuvant therapy, capecitabine is given at 1000-1250 mg\u002Fm² twice daily on a 2-week-on-1-week-off schedule for 6-8 cycles; for patients without prior neoadjuvant therapy, capecitabine is given at 650 mg\u002Fm² twice daily for 1 year.",[15],[32],{"facility":33,"status":26,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Fudan University Shanghai Cancer Center, Shanghai, Shanghai 200032","Shanghai","Shanghai Municipality","200032","China","CN",{"type":40,"coordinates":41},"Point",[42,43],121.45806,31.22222,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Keda Yu Professor","CONTACT","+86-021-64175590","yukeda@fudan.edu.cn",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Keda Yu","Professor","100637248","phase-3-sac-tmt-sequential-capecitabine-versus-capecitabine-in-early-stage-high-risk-triple-negative-breast-cancer-without-brca-mutations-100637248",false,"NCT07628504","Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Breast Cancer Without BRCA Mutations","Sacituzumab Tirumotecan (Sac-TMT) Sequential Capecitabine Versus Capecitabine as Adjuvant Regimen for Triple-Negative Breast Cancer With Early-Stage, High-Risk, Non-BRCA Mutated Status: A Phase III, Randomized, Controlled, Open-Label, Multicenter Clinical Trial","STARTER","Inclusion Criteria:\n\n1. Female aged ≥ 18 years old.\n2. Diagnosis of operable primary invasive breast cancer.\n3. Negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER2), defined as follows: ER-negative is defined as \\\u003C10 % positive tumor cells by immunohistochemistry (IHC); PR-negative is defined as \\\u003C10 % positive tumor cells by IHC; HER2-negative is defined as IHC score of 0 or 1+, or IHC score of 2+ with negative (non-amplified) results confirmed by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH).\n4. Non-mutated for BRCA1\u002F2 genes.\n5. Patients must satisfy any one of the following conditions:\n\n   1. Baseline clinical lymph node-positive (cLN+) or pathological lymph node-positive (pN+) status with non-pathological complete response (non-pCR), who have completed adequate neoadjuvant therapy (at least 6 cycles of chemotherapy containing anthracycline and\u002For taxane, with or without PD-1 inhibitor immunotherapy).\n   2. Pathological lymph node-positive (pN+) status without prior neoadjuvant therapy, who have undergone adequate surgery, adjuvant chemotherapy (at least 6 cycles of taxane- and\u002For anthracycline-containing regimen with or without carboplatin), and adjuvant radiotherapy (if applicable).\n6. No evidence of distant metastasis shown by imaging examinations performed within 3 months prior to randomization.\n7. Adequate organ and bone marrow function.\n8. Acute toxicities from any prior therapy have recovered to baseline levels or resolved to Grade ≤ 1 per NCI CTCAE Version 5.0 (excluding adverse events deemed non-safety risks at the investigator's discretion).\n9. Post-menopausal status or documented non-childbearing potential. For women of childbearing potential, urine pregnancy tests must be negative at post-surgery screening and baseline visits. All participants and their male partners of childbearing potential must use effective medical contraception from the date of informed consent signature until 6 months after the last dose of study treatment.\n10. Voluntarily participate in the study, provide written informed consent, and be able to comply with protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n1. Patients with Stage T4 disease, including those with inflammatory breast cancer;\n2. Patients with Stage N3 disease;\n3. Patients with positive supraclavicular or internal mammary lymph nodes;\n4. Previous history of breast cancer;\n5. Significant cardiovascular diseases such as baseline left ventricular ejection fraction (LVEF) \\\u003C 50% assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan at screening, or New York Heart Association (NYHA) Class III or IV cardiomyopathy;\n6. Prior treatment with TROP2-targeted therapy and\u002For topoisomerase I inhibitors;\n7. History of other malignant neoplasms within the past 5 years, excluding cured carcinoma in situ of the cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma;\n8. Known hypersensitivity to study drugs and their components, history of immunodeficiency, or history of organ transplantation;\n9. History of non-infectious interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy, current ILD or non-infectious pneumonia, or suspected ILD\u002Fnon-infectious pneumonia that cannot be ruled out by imaging at screening; clinically significant severe pulmonary impairment secondary to concomitant pulmonary diseases, including but not limited to any underlying pulmonary disorders (e.g., pulmonary embolism within 3 months prior to first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) or any autoimmune, connective tissue, or inflammatory diseases potentially involving the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis), or prior pneumonectomy;\n10. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of corneal disorders that hinder delayed corneal healing;\n11. Active autoimmune diseases requiring systemic therapy within the past 2 years (hormone replacement therapy is not considered systemic therapy, e.g., type 1 diabetes mellitus, hypothyroidism managed with thyroid hormone replacement only, adrenal or pituitary insufficiency managed with physiological-dose glucocorticoid replacement only);\n12. Active infections requiring systemic therapy within 2 weeks prior to the first dose;\n13. Patients with malabsorption syndromes affecting glucuronosyltransferase (Gl) function, history of gastric or small bowel resection, or inability to swallow capecitabine tablets;\n14. Concomitant severe diseases that jeopardize patient safety or interfere with study completion as judged by the investigator, including but not limited to uncontrolled hypertension, severe diabetes mellitus, and active infections;\n15. Any other conditions rendering the patient ineligible for study participation in the investigator's opinion.","FEMALE","18 Years",{"count":66,"type":67},420,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","The goal of this clinical trial is to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT) sequential capecitabine versus single-agent capecitabine as adjuvant intensified therapy in patients with high-risk early-stage triple-negative breast cancer (TNBC) without BRCA mutations.\n\nThe main questions it aims to answer are:\n\n1. Does sacituzumab tirumotecan (sac-TMT) sequential capecitabine improve survival outcomes compared with capecitabine monotherapy in this patient population?\n2. What is the safety profile of sacituzumab tirumotecan (sac-TMT)-containing adjuvant therapy versus capecitabine monotherapy? Researchers will compare the sacituzumab tirumotecan (sac-TMT)-sequential-capecitabine experimental arm with the capecitabine-alone control arm to see if the experimental regimen provides superior adjuvant anti-tumor efficacy with acceptable safety.\n\nParticipants will be randomized in a 1:1 to Receive assigned study treatment as follows:\n\nExperimental arm: Sacituzumab tirumotecan (sac-TMT) 4 mg\u002Fkg intravenously on Day 1 of each 3-week cycle for 8 cycles, followed by sequential capecitabine at stratified doses; patients with prior PD-1\u002FL1 inhibitor exposure will continue PD-1\u002FL1 inhibitor therapy for up to 1 year Control arm: Capecitabine monotherapy at stratified doses; patients with prior PD-1\u002FL1 inhibitor exposure will continue PD-1\u002FL1 inhibitor therapy for up to 1 year",[73],"Adjuvant Drug Therapy","NOT_YET_RECRUITING","2026-06-04",{"date":77,"type":78},"2026-06-05","ACTUAL",{"date":80,"type":67},"2026-05-18",{"date":82,"type":67},"2035-03-30",{"name":5,"class":6},1]