[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576595":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":39,"studyPopulation":32,"armGroups":40,"interventions":47,"overallOfficials":32,"centralContacts":52,"locations":61,"responsibleParty":86,"collaborators":32,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":32,"enrollmentInfo":99,"targetDuration":32,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":64,"whyStopped":32,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"RFS","recurrence free survival","3 years",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"iDFS","invasive disease-free survival",{"measure":18,"description":19,"timeFrame":12},"DRFS","distant relapse-free survival",{"measure":21,"description":22,"timeFrame":12},"DFS","disease-free survival",{"measure":24,"description":25,"timeFrame":12},"OS","overall survival",{"measure":27,"description":28,"timeFrame":12},"adverse events","adverse events according to CTCAE 5.0",{"measure":30,"description":31,"timeFrame":12},"PRO","patient reported outcome",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"NA","SINGLE_GROUP","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE","This study aims to evaluate the efficacy and safety of capecitabine as the only adjuvant chemotherapy drug in patients with low-risk T1N0M0 early triple-negative breast cancer who have received adequate local treatment. Patients meeting the inclusion criteria will receive capecitabine metronomic therapy for one year. The low-risk population defined in this study includes the IM subtype with abundant stromal tumor-infiltrating lymphocytes, or the LAR subtype with low ki-67 proliferation, or elderly patients.",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Capecitabine","EXPERIMENTAL","capecitabine metronomic therapy for one year",[46],"Drug: Capecitabine",[48],{"type":49,"name":42,"description":50,"armGroupLabels":51,"otherNames":32},"DRUG","Capecitabine 650mg\u002Fm2, bid, p.o for 1 year",[42],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":32,"email":57},"Zhimin C Shao","CONTACT","02164175590","zhimingshao@yahoo.com",{"name":59,"role":55,"phone":56,"phoneExt":32,"email":60},"Yin Liu","liuyinfudan@163.com",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":32,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"breast cancer institute of Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":70,"coordinates":71},"Point",[72,73],121.45806,31.22222,{"lat":73,"lon":72},[76,79,81,84],{"name":77,"role":55,"phone":78,"phoneExt":32,"email":57},"Zhimin Shao, MD","86-021-641755901105",{"name":80,"role":55,"phone":56,"phoneExt":32,"email":60},"Yin Liu, MD",{"name":82,"role":83,"phone":32,"phoneExt":32,"email":32},"Zhi-Ming Shao, MD","PRINCIPAL_INVESTIGATOR",{"name":59,"role":85,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"type":83,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Zhimin Shao","Professor","100576595","phase-2-capecitabine-in-low-risk-triple-negative-breast-cancer-100576595",false,"NCT06787339","Capecitabine in Low Risk Triple Negative Breast Cancer","A Prospective, Single-arm,Clinical Trial Exploring the Efficacy and Safety of Chemotherapy De-escalation Using Capecitabine in Low-risk Early Triple-negative Breast Cancer","Calorite","Inclusion Criteria:\n\n1. Male and female patients aged ≥18 years;\n2. Pathological confirmed of stage I breast cancer: histologically confirmed that the longest diameter of invasive cancer is no more than 2cm and the lymph node is negative (N0);\n3. Histologically documented TNBC after early breast cancer surgery (absence of HER2, ER, and PR expression)\n4. Patients who have undergone standard and adequate surgical treatment;\n5. Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g\u002FL (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 \u002FL; platelet count ≥ 100 \\* 109 \u002FL; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of \\>50 ml\u002Fmin (Cockcroft-Gault formula);\n6. No evidence of metastasis in clinical or imaging examinations before surgery, that is, M0;\n7. ECOG score of 0 or 1;\n8. Meeting one of the low-risk criteria defined in this study: a) IM subtype, that is, the proportion of stromal tumor-infiltrating lymphocytes is high or CD8 is high; b) LAR subtype and ki-67 less than 20%; c) Age ≥ 70 years.\n\n8)The patient voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy;\n2. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ;\n3. Has metastic (Stage 4) breast cancer;\n4. Pregnant or breast feeding women, or people of childbearing age who cannot practice effective contraceptives;\n5. Patients participating in other clinical trials at the same time;\n6. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \\\u003C 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\\>150\u002F90mmHg, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; Has severe or uncontrolled infection; 7) Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders; 8)The researchers considered patients to be unsuitable for the study. 9)Has bilateral breast cancer","ALL","18 Years",{"count":100,"type":101},198,"ESTIMATED","INTERVENTIONAL",[104],"PHASE2","This study aims to evaluate the efficacy and safety of capecitabine as the only adjuvant chemotherapy drug in patients with low-risk early triple-negative breast cancer who have received adequate local treatment. Patients meeting the inclusion criteria will receive capecitabine metronomic therapy for one year.",[107],"Breast Cancer",[109,110],"adjuvant chemotherapy de-escalation","triple negative breast cancer","2026-09-24",{"date":113,"type":114},"2026-09-28","ACTUAL",{"date":116,"type":114},"2025-01-20",{"date":118,"type":101},"2030-01-31",{"name":5,"class":6},1]