[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600896":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":26,"collaborators":11,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":11,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":11,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"West China Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AK112 combining Nab-paclitaxel and carboplatin","EXPERIMENTAL",null,[13],"Drug: AK112, Carboplatin, Paxlitaxel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","AK112, Carboplatin, Paxlitaxel","The combination of AK112, a platinum-based chemotherapy agent, and Paxlitaxel is administered every three weeks as a neoadjuvant treatment for triple-negative breast cancer. After completing six cycles of this regimen, the participant undergoes surgical treatment.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Ting Luo","CONTACT","86 +18980606230","luoting@wchscu.cn",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Shuangyue Liu","Chief physician","100600896","phase-2-prospective-multicenter-single-arm-trial-ak112--nab-paclitaxelcarboplatin-neoadjuvant-for-tnbc-100600896",false,"NCT07103447","Prospective Multicenter Single-arm Trial: AK112 + Nab-paclitaxel\u002FCarboplatin Neoadjuvant for TNBC","A Prospective, Multicenter, Single-Arm Study of AK112 in Combination With Albumin-Bound Paclitaxel and Carboplatin as Neoadjuvant Treatment for Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Voluntary Participation and Informed Consent: The participant voluntarily agrees to join this clinical trial, signs a written informed consent form, understands the study, and is willing to comply with all trial procedures.\n2. Eligibility by Age and Gender: Female participants aged ≥18 years and ≤75 years on the day of signing the informed consent form.\n3. Pathological Confirmation of Disease: Histopathologically confirmed diagnosis of T1-4N0-3M0 (except for T1N0M0) triple-negative invasive breast cancer, defined as negative for estrogen receptor (ER) and progesterone receptor (PgR) (immunohistochemistry: ER, PR \\\u003C 1%), and human epidermal growth factor receptor 2 (HER2) (immunohistochemistry HER2 \"0\\~1+\"; or immunohistochemistry HER2 \"2+\" with no amplification on HER2 FISH gene testing).\n4. Measurable Lesion: At least one lesion measurable according to RECIST v1.1 criteria. Participants diagnosed at an external institution agree to provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded \\[FFPE\\] tissue blocks or at least 25 unstained tumor tissue slides) for pathology review.\n5. Planned Surgical Treatment: Participants are scheduled to undergo definitive surgical resection of breast cancer, including either breast-conserving surgery or mastectomy, along with sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND), and are planned to receive neoadjuvant chemotherapy.\n\nExclusion Criteria:\n\n1. Prior Anti-Cancer Treatments.\n2. Received systemic anti-cancer treatment, including chemotherapy, radiotherapy, immunotherapy, targeted therapy (within 2 weeks for small molecule targeted therapies), or biological agent treatment within 4 weeks before enrollment.\n3. Received palliative local treatments within 2 weeks before enrollment.\n4. Received systemic non-specific immune modulatory treatments (e.g., interleukins, interferons, thymopeptides) within 2 weeks before enrollment.\n5. Received traditional Chinese medicine or Chinese patent medicines with anti-cancer indications within 2 weeks before enrollment.\n6. Prior PD-1\u002FPD-L1 Treatment.\n7. Previously received treatment with PD-1 inhibitors or PD-L1 inhibitors.\n8. Concurrent Participation in Other Clinical Studies.\n9. Currently participating in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study.\n10. History of Other Malignancies:\n\n(1) Has a history of other malignant tumors within 5 years prior to enrollment or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and thyroid cancer.\n\n(2) Active Autoimmune Diseases: Has active autoimmune diseases that required systemic treatment (such as corticosteroids) within 2 years before enrollment, or has autoimmune diseases that the investigator judges may recur or require planned treatment.","FEMALE","18 Years","75 Years",{"count":41,"type":42},54,"ESTIMATED","INTERVENTIONAL",[45],"PHASE2","This prospective, multicenter, single-arm clinical study aims to evaluate the efficacy and safety of AK112 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant treatment in adult women with early or locally advanced triple-negative breast cancer (TNBC). The study seeks to address the pathological complete response (pCR) rate, objective response rate (ORR), breast conservation rate, and invasive disease-free survival (iDFS) following treatment with AK112 combined with albumin-bound paclitaxel and carboplatin in early or locally advanced TNBC.",[48],"Breast Cancer - Female",[50],"AK112 combining chemothrapy, neoadjuvant therapy, TNBC","NOT_YET_RECRUITING","2025-08-02",{"date":54,"type":55},"2025-08-05","ACTUAL",{"date":57,"type":42},"2025-09-10",{"date":59,"type":42},"2028-12-31",{"name":28,"class":6}]