[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"newly-diagnosed-triple-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:newly-diagnosed-triple-negative-breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100659705","phase-3-a-multicenter-randomized-controlled-phase-iii-clinical-trial-on-adjuvant-intensified-therapy-for-patients-with-residual-disease-after-neoadjuvant-treatment-for-triple-negative-breast-cancer-100659705",false,"NCT07869628","A Multicenter, Randomized, Controlled Phase III Clinical Trial on Adjuvant Intensified Therapy for Patients With Residual Disease After Neoadjuvant Treatment for Triple-negative Breast Cancer","CREATE","Inclusion Criteria:\n\n\\- Before implementing any trial-related procedures, sign a written informed consent.\n\n\\- Female, aged 18 years or above, and under 75 years old.\n\n\\- ECOG PS 0-1.\n\n\\-\n\nPrimary invasive breast cancer confirmed by initial pathology:\n\n1. Tumor stage: II-IIIc, without internal mammary lymph node and supraclavicular lymph node metastasis\n2. HER2 negative: defined as IHC 0 or IHC 1+ or IHC 2+ and FISH -7 \u002F 32\n3. Estrogen receptor (ER) and progesterone receptor (PR) negative: \\\u003C1%.\n\n   \\- Received standard and complete course of neoadjuvant therapy (neoadjuvant chemotherapy + immunotherapy) as per the guidelines.\n\n   \\- After neoadjuvant treatment, received standard radical surgery and postoperative pathology indicated the presence of residual lesions (remaining invasive cancer foci in the breast and\u002For positive axillary lymph nodes), and the residual lesions were confirmed by immunohistochemistry to still be TNBC.\n\n   \\- Female patients with fertility must agree to use effective contraceptive methods during the study period and within 6 months after the last study medication.\n\nPregnancy tests (urine or serum) for women of childbearing age must be negative .\n\n\\-\n\nThe main organs function normally (within 14 days before enrollment), meeting the following criteria:\n\n1. The criteria for blood routine examination should be met (within 14 days before enrollment, no blood transfusion and no treatment with granulocyte colony-stimulating factor):\n\n   1. Hemoglobin (HB) ≥ 90g\u002FL;\n   2. Neutrophils (ANC) ≥ 1.0×10\\^9\u002FL;\n   3. Platelets (PLT) ≥ 75×10\\^9\u002FL;\n2. No organic functional diseases, meeting the following criteria:\n\n   1. Serum total bilirubin ≤ 1.5 X ULN or direct bilirubin ≤ ULN (total bilirubin level \\> 1.5 ULN)\n   2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;\n   3. Alkaline phosphatase ALP, if greater than 2.5 X ULN, then the liver fraction should be ≤ 2.5 X ULN\n   4. Serum creatinine level Cr ≤ 1.5xULN or calculated creatinine clearance rate (using MDRD formula) ≥ 40ml\u002Fmin and Cr \\> 1.5xULN\n   5. Urine protein \\\u003C 2+, if the test strip ≥ 2+, then 24-hour urine protein must be \\\u003C 2g, or urine albumin-to-creatinine ratio (UPC) must be \\\u003C 2\n   6. International normalized ratio (INR), activated partial thromboplastin time (aPTT): ≤ 1.5×ULN.\n\n      Exclusion Criteria:\n\n      \\- Stage IV metastatic breast cancer.\n\n      \\- Inflammatory breast cancer.\n\n      \\- Bilateral primary breast cancer (including invasive cancer and carcinoma in situ).\n\n      \\- New adjuvant therapy that has not completed the full course.\n\n      \\- Achieved pCR after neoadjuvant therapy.\n\n      \\- Previously received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured cases of cervical carcinoma in situ, skin basal cell carcinoma and squamous cell carcinoma.\n\n      \\- Receiving any hormonal therapy (such as contraceptives, ovarian hormone replacement therapy, etc.), or any hormonal drugs (such as raloxifene, tamoxifen, or other selective estrogen receptor modulators) for the treatment of osteoporosis or breast cancer prevention.\n\n      \\- Within 4 weeks before randomization, underwent major surgical procedures unrelated to breast cancer or the patient has not fully recovered.\n\n      \\- Symptomatic peripheral neuropathy evaluated by CTCAE 5.0 grade ≥ 2.\n\n      \\-\n\n      Severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n   \u003C!-- -->\n\n   1. History of congestive heart failure or systolic dysfunction (LVEF \\\u003C 50%);\n   2. Angina pectoris requiring anti-anginal drugs;\n   3. High-risk uncontrolled arrhythmias or severe conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, etc.; average QTcF \\> 470ms during rest;\n   4. Cardiac valve disease with cardiac dysfunction;\n   5. Uncontrolled hypertension;\n   6. History of myocardial infarction.\n\n      \\- Has had any allergy to any component of the drugs in this protocol.\n\n      \\- Not suitable for using corticosteroids.\n\n      \\- Has active infection and currently requires systemic anti-infection treatment.\n\n      \\- History of immunodeficiency, including positive HIV test, or having other acquired or congenital immune deficiency diseases, or having a history of organ transplantation.\n\n      \\- Participated in other intervention drug clinical trials within 28 days before randomization, or simultaneously participated in another clinical trial or used other investigational treatments.\n\n      \\- Pregnant (positive pregnancy test), lactating patients.\n\n      \\- Any other comorbid diseases that interfere with the implementation of the treatment plan, or the investigator believes that the subject has other serious systemic disease history, or other reasons that make it inappropriate to participate in this trial.","FEMALE","18 Years","75 Years",{"count":20,"type":21},852,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is a multicenter, randomized controlled phase III clinical trial. The aim of this study is to observe the efficacy and safety of PD-1 inhibitors combined with capecitabine, PD-1 inhibitors alone, or capecitabine alone in patients with TNBC who have residual lesions after neoadjuvant treatment.\n\nThe subjects will be randomly assigned in a 1:1:1 ratio to Group A (capecitabine combined with PD-1 inhibitor), Group B (PD-1 inhibitor), and Group C (capecitabine). The stratification factors are the lymph node metastasis status (lymph node metastasis negative ypN0, lymph node metastasis positive ypN1-3) and PD-L1 status (negative\u002Fpositive) after neoadjuvant treatment.\n\nGroup A: Capecitabine, 1250mg\u002Fm2, twice a day, 14\u002F21 days, combined with PD-1 inhibitor, for a total of 8 cycles Group B: PD-1 inhibitor, for a total of 8 cycles Group C: Capecitabine, 1250mg\u002Fm2, twice a day, 14\u002F21 days, for a total of 8 cycles The study will include approximately 10 centers. After the completion of NAT (chemotherapy + immunotherapy), 852 patients with residual lesions (breast still has invasive cancer lesions remaining and\u002For positive axillary lymph nodes) will be enrolled, with 284 patients in each of Groups A, B, and C. After surgery, clinicians will, based on clinical treatment guidelines and the clinical practices of each center, administer radiotherapy to subjects with indications for radiotherapy.\n\nDuring radiotherapy, the use of capecitabine and\u002For immunotherapy is decided by the supervising doctor as either concurrent or sequential.",[27],"Newly Diagnosed Triple-negative Breast Cancer","NOT_YET_RECRUITING","2026-10-07",{"date":31,"type":32},"2026-10-09","ACTUAL",{"date":34,"type":21},"2026-10-17",{"date":36,"type":21},"2034-08-31",{"name":38,"class":39},"Shandong Cancer Hospital and Institute","OTHER"]