[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619258":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":20,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":20,"eligibilityCriteria":50,"healthyVolunteers":47,"sex":51,"minAge":52,"maxAge":20,"enrollmentInfo":53,"targetDuration":20,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":20,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Affiliated Hospital of Nantong University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"experimental group","EXPERIMENTAL","QL1706 plus carboplatin and albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 plus doxorubicin\u002Fepirubicin and cyclophosphamide (21-day cycles for 4 cycles)",[13],"Drug: Immunotherapy combined with chemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Immunotherapy combined with chemotherapy","Albumin-bound paclitaxel: 125 mg\u002Fm², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg\u002Fkg, day 1, 21-day cycle; Epirubicin: 90-100 mg\u002Fm², day 1, 21-day cycle; or Doxorubicin: 50 mg\u002Fm², day 1, 21-day cycle; Cyclophosphamide: 600 mg\u002Fm², day 1, 21-day cycle.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Liu Fan","CONTACT","86+18912250939","lflove2009@126.com",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Nantong","Jiangsu","China","CN",{"type":35,"coordinates":36},"Point",[37,38],120.87472,32.03028,{"lat":38,"lon":37},[41],{"name":20,"role":24,"phone":42,"phoneExt":20,"email":20},"0513 8505 2222",{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100619258","phase-2-ql1706-plus-chemotherapy-as-neoadjuvant-therapy-in-triple-negative-breast-cancer-100619258",false,"NCT07342283","QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed newly diagnosed ER-\u002FHER2- breast cancer. ER and PR with Allred score \\\u003C3 or \\\u003C1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines;\n2. Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy;\n3. Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size;\n4. Treatment-naïve subjects;\n5. Age ≥18 years, both genders eligible;\n6. ECOG performance status 0-1;\n7. Adequate bone marrow, cardiac, and organ function;\n8. Women of childbearing potential must have a negative pregnancy test (serum or urine HCG) within 30 days prior to study enrollment and must practice effective contraception during the study;\n9. Ability to comprehend and provide written informed consent.\n\nExclusion Criteria:\n\n1. History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;\n2. Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;\n3. Stage IV metastatic breast cancer;\n4. Administration of a vaccine within 30 days before the first dose of the study treatment;\n5. Subjects with severe systemic diseases;\n6. Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);\n7. Severe cardiovascular diseases, such as: history of myocardial infarction, acute coronary syndrome, or coronary angioplasty\u002Fstenting\u002Fbypass grafting within the past 6 months; or congestive heart failure (CHF) of New York Heart Association (NYHA) class II-IV, or history of CHF NYHA class III or IV;\n8. Lactating women should discontinue breastfeeding during the study;\n9. Subjects with known allergies to the study drug or any of its excipients;\n10. Any other condition deemed inappropriate for participation in the study by the investigator.\n\n    \\-","ALL","18 Years",{"count":54,"type":55},30,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","This is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin\u002Fepirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.",[61],"Triple Negative Breast Cancer (TNBC)","2026-02-26",{"date":64,"type":65},"2026-03-02","ACTUAL",{"date":67,"type":65},"2026-02-25",{"date":69,"type":55},"2028-12-25",{"name":5,"class":6},1]