[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612536":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"First Affiliated Hospital of Wenzhou Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Chemotherapy+Immunotherapy","EXPERIMENTAL","Control Group: Neoadjuvant chemotherapy combined with immunotherapy, wherein the neoadjuvant chemotherapy regimen follows the clinical standard protocol.\n\nNeoadjuvant Chemotherapy Regimen:\n\nA sequential chemotherapy strategy is adopted, with the specific regimen as follows:\n\nTaxane-based Chemotherapy Phase (T Phase):\n\nNab-paclitaxel (125 mg\u002Fm²), administered by intravenous infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 4 cycles.\n\nAnthracycline-based Combination Chemotherapy Phase (EC Phase):\n\nEpirubicin (75-100 mg\u002Fm²) in combination with cyclophosphamide (600 mg\u002Fm²), administered by intravenous infusion every 21 days (Q3W), for a total of 4 cycles.\n\nThe EC phase commences upon completion of the T phase.\n\nImmunotherapy Regimen:\n\nSintilimab (200 mg), administered by intravenous infusion every three weeks (Q3W).\n\nDosing begins on Day 2 of the chemotherapy cycles, for a total of 8 treatment cycles.",[13,14],"Drug: Neoadjuvant Chemotherapy (NACT)","Drug: Immunotherapy (Sintilimab)",{"label":16,"type":10,"description":17,"interventionNames":18},"Chemotherapy + Immunotherapy + Radiotherapy","Neoadjuvant chemotherapy combined with immunotherapy（same as Arm1) + Neoadjuvant Radiotherapy",[19,13,14],"Radiation: Neoadjuvant radiotherapy",[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Neoadjuvant radiotherapy","Neoadjuvant Radiotherapy Regimen:\n\n1. Radiotherapy Technique: Stereotactic Body Radiation Therapy (SBRT) Radiation Dose and Fractionation: 8 Gy per fraction, for a total of 3 fractions, amounting to a total dose of 24 Gy\n2. Radiotherapy Schedule: Irradiation begins on the second day of the first chemotherapy cycle and is administered every other day\n3. Target Volume Definition: The radiotherapy target volume is defined based on baseline imaging (e.g., CT, MRI, or PET-CT)\n4. Radiotherapy Equipment and Planning: Treatment is delivered using a linear accelerator equipped with Image-Guided Radiotherapy (IGRT) technology to ensure precise irradiation and dose optimization",[16],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Neoadjuvant Chemotherapy (NACT)","Neoadjuvant Chemotherapy Regimen:\n\nA sequential chemotherapy strategy is adopted, with the specific regimen as follows:\n\nTaxane-based Chemotherapy Phase (T Phase):\n\nNab-paclitaxel (125 mg\u002Fm²), administered by intravenous infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 4 cycles.\n\nAnthracycline-based Combination Chemotherapy Phase (EC Phase):\n\nEpirubicin (75-100 mg\u002Fm²) in combination with cyclophosphamide (600 mg\u002Fm²), administered by intravenous infusion every 21 days (Q3W), for a total of 4 cycles.\n\nThe EC phase commences upon completion of the T phase.",[16,9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Immunotherapy (Sintilimab)","Immunotherapy Regimen:\n\nSintilimab (200 mg), administered by intravenous infusion every three weeks (Q3W).\n\nDosing begins on Day 2 of the chemotherapy cycles, for a total of 8 treatment cycles.",[16,9],[37],{"facility":38,"status":26,"city":39,"state":40,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The First Affiliated Hospital of Wenzhou Medical University","Wenzhou","Zhejiang","China","CN",{"type":44,"coordinates":45},"Point",[46,47],120.66682,27.99942,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":53,"phoneExt":26,"email":54},"Professor Wang","CONTACT","86+13957706099","woc099@163.com",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Wang Ouchen","Chief Physician","100612536","phase-2-combined-chemo-immunotherapy-plus-sbrt-in-neoadjuvant-treatment-for-luminal-subtype-breast-cancer-100612536",false,"NCT07254858","Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer","Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer: A Prospective Multicenter Randomized Controlled Trial","CISN-L","Inclusion Criteria:\n\n1. Newly diagnosed, untreated breast cancer;\n2. Age: 18 years ≤ age ≤ 75 years;\n3. Histologically confirmed hormone receptor-positive (HR+) tumor specimen (estrogen receptor \\[ER\\] ≥ 10%);\n4. Human epidermal growth factor receptor-2 immunohistochemistry (HER2-IHC) result of 0\u002F1+ or 2+ with negative fluorescence in situ hybridization (FISH) test;\n5. Histologically confirmed cell proliferation index (Ki67) ≥ 20%;\n6. Programmed death-ligand 1 combined positive score (PD-L1 CPS) evaluable (i.e., availability of fresh\u002Farchived specimens);\n7. Good pulmonary function;\n8. Adequate hepatic and renal function;\n9. Histological grade ≥ 2;\n10. cN0, cT ≥ 3 cm or cN1-3, cT ≥ 2 cm (cT: clinically assessed maximum diameter of primary tumor; cN: clinically assessed regional lymph node status);\n11. Eastern Cooperative Oncology Group Performance Status (ECOG score) 0-1. Exclusion Criteria:\n\n1.Pregnancy; 2.Tumor \\> 8 cm with skin ulceration; 3.History of thoracic radiotherapy or contraindications to radiotherapy; 4.Active autoimmune disease; 5.Prior use of PD-L1 antibody therapy; 6.De novo breast cancer; 7.There are factors that may significantly increase the risk of lung or cardiac toxicity related to radiotherapy, such as (1) maximum lung depth(MLD) \\>3.2cm； (2) maximum heart distance(MHD) \\\u003C2.4cm。","FEMALE","18 Years","75 Years",{"count":71,"type":72},302,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy and safety of combining radiotherapy, chemotherapy, and immunotherapy in the neoadjuvant treatment of high-risk HR+\u002FHER2- breast cancer patients.\n\nThe study plans to enroll treatment-naïve HR+\u002FHER2- breast cancer patients aged 18-75 with high-risk features (e.g., tumor size ≥3 cm or lymph node positivity, Ki-67 ≥20%). Eligible subjects will be randomized in a 1:1 ratio into two groups: the control group will receive neoadjuvant chemotherapy (nab-paclitaxel followed by epirubicin + cyclophosphamide) in combination with sintilimab immunotherapy; the experimental group will receive the same chemotherapy and immunotherapy regimen with the addition of stereotactic body radiotherapy (SBRT) administered early during treatment, at a prescribed dose of 8 Gy per fraction for 3 fractions, with one fraction per day.\n\nThe study has dual primary endpoints: pathological complete response (pCR,) and objective response rate (ORR ). Secondary endpoints include 3-year event-free survival (EFS), incidence of adverse events (CTCAE v5.0), and postoperative cosmetic outcomes of the breast. The study design incorporates hierarchical testing to control for multiplicity, and long-term follow-up is planned to evaluate survival benefits.\n\nThe study has been approved by the ethics committee, and all participants are required to provide written informed consent. The results are expected to offer a novel neoadjuvant treatment strategy for high-risk HR+\u002FHER2- breast cancer patients and improve their therapeutic outcomes.",[78],"HR+\u002FHER2- Breast Cancer",[80,81,82],"Breast Cancer","Radiotherapy","Immunotherapy","NOT_YET_RECRUITING","2025-11-20",{"date":86,"type":87},"2025-11-28","ACTUAL",{"date":89,"type":72},"2025-12",{"date":91,"type":72},"2029-12-30",{"name":5,"class":6},1]