[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586366":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":53,"locations":59,"responsibleParty":86,"collaborators":26,"id":88,"slug":26,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":26,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":26,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Xijing Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","During the neoadjuvant treatment period, participants will undergo stereotactic radiotherapy and subsequently receive chemotherapy combined with immunotherapy.",[13,14,15,16,17,18,19],"Radiation: Stereotactic Body Radiation Therapy (SBRT)","Drug: Toripalimab","Drug: Neoadjuvant Chemotherapy","Procedure: Surgery","Drug: Adjuvant Chemotherapy","Radiation: Adjuvant Radiotherapy","Drug: Endocrine therapy",[21,27,32,36,41,45,49],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Stereotactic Body Radiation Therapy (SBRT)","The prescribed dose of radiation is 24 Gy delivered in 3 fractions (8 Gy\u002Ffraction) using SBRT technique. Subjects received SBRT for the primary breast cancer lesion at 8Gy\u002FFraction each time for 3 consecutive days, 1 week before the start of systemic therapy. The first day of radiation is C1D1.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Toripalimab","Toripalimab will be administered at a fixed dose of 240 mg via intravenous infusion every 3 weeks (q3w). The first dose is given on Cycle 2 Day 1 (C2D1), followed by dosing on the first day of each subsequent cycle for a total of 4 cycles. (Toripalimab×4 240mg D1 q3w)",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Neoadjuvant Chemotherapy","Combined with Toripalimab, Nab-paclitaxel will be dosed at 125 mg\u002Fm² based on body surface area, administered by intravenous infusion weekly (Days 1, 8, 15 of each 21-day cycle) for 4 cycles.(T×4, Nab-Paclitaxel 125mg\u002Fm2，D1、D8、D15 q3w).",[9],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":26},"PROCEDURE","Surgery","Surgery will be performed 2-6 weeks after completion of neoadjuvant therapy. The surgical approach will be determined by the investigator based on disease status and patient preference.",[9],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":26},"Adjuvant Chemotherapy","The anthracycline may be either Epirubicin (body surface area-adjusted 50 mg\u002Fm²) or Liposomal Doxorubicin (body surface area-adjusted 30 mg\u002Fm²) combined with Cyclophosphamide (body surface area-adjusted 600 mg\u002Fm²). Both drugs were administered intravenously every 3 weeks, and then the first day of each course was administered for 4 cycles. (EC×4, Epirubicin 50 mg\u002Fm² or Liposomal Doxorubicin 30 mg\u002Fm², comined with Cyclophosphamide 600 mg\u002Fm², D1, q3w)",[9],{"type":22,"name":46,"description":47,"armGroupLabels":48,"otherNames":26},"Adjuvant Radiotherapy","Conventional radiotherapy will be delivered to the breast\u002Fchest wall and regional lymph nodes (investigator-selected technique), with explicit prohibition of tumor bed boost irradiation.",[9],{"type":28,"name":50,"description":51,"armGroupLabels":52,"otherNames":26},"Endocrine therapy","Investigator-selected adjuvant endocrine therapy will be deterimend according to applicable guidelines, considering menopausal status, recurrence risk, treatment history, comorbidities as well as patient preference.",[9],[54],{"name":55,"role":56,"phone":57,"phoneExt":26,"email":58},"JIAJUN DING","CONTACT","15121089323","yuki_ding1996@163.com",[60,78],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Xijing Hospital Affiliated to Air Force Military Medical University","RECRUITING","Xi'an","Shannxi Province","710032","China",{"type":68,"coordinates":69},"Point",[70,71],108.92861,34.25833,{"lat":71,"lon":70},[74],{"name":75,"role":56,"phone":76,"phoneExt":26,"email":77},"Ting Wang, PhD","0086-13700283101","ting_w100@126.com",{"facility":61,"status":62,"city":63,"state":79,"zip":26,"country":66,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"Shannxi",{"type":68,"coordinates":81},[70,71],{"lat":71,"lon":70},[84],{"name":85,"role":56,"phone":76,"phoneExt":26,"email":77},"Ting Wang",{"type":87,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100586366",false,"NCT06914440","Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+\u002FHER2- Breast Cancer","Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+\u002FHER2- Breast Cancer: A Single-arm, Prospective Clinical Trial","Inclusion Criteria:\n\n1. Female patients aged ≥18 and ≤75 years at the time of signing informed consent.\n2. ECOG PS status of 0-1.\n3. Breast cancer assessed as non-metastatic (M0), meeting all of the following:\n\n   1. Clinical stage: Stage IIB, IIIA, IIIB, or IIIC\n   2. Required imaging assessments (within 28 days): Abdominal CT, ECT Bone scan, Chest CT and Brain MRI\n4. Histologically or pathologically confirmed invasive carcinoma of no special type, with all of the following:\n\n   1. Grade 2 or 3 (confirmed by central laboratory);\n   2. ER-positive (\\>1% staining) and\u002For PR-positive (\\>1% staining) by IHC;\n   3. HER2-negative (IHC 0\u002F1+ or HER2\u002Fneu FISH ratio ≤1.8);\n   4. Ki-67 ≥15%.\n5. Patient deemed eligible for radiotherapy after MDT evaluation.\n6. No prior antitumor therapy within 1 month before enrollment.\n7. Organ Function Requirements (within 7 days prior to enrollment):\n\n   1. Complete blood count (no transfusion or hematopoietic growth factors within 7 days): ANC ≥1.5×10⁹\u002FL; ALC ≥0.5×10⁹\u002FL; Platelets ≥100×10⁹\u002FL; Hemoglobin ≥90 g\u002FL; WBC ≥3.0×10⁹\u002FL and ≤15×10⁹\u002FL;\n   2. Blood biochemistry (no transfusion\u002Falbumin within 7 days): ALT\u002FAST ≤2.5×ULN; ALP ≤2.5×ULN；BUN\u002FCr ≤1.5×ULN; Cr≥60 mL\u002Fmin (Cockcroft-Gault formula);\n   3. Coagulation: PT\u002FAPTT ≤1.5×ULN; INR ≤1.5×ULN (if no anticoagulant therapy);\n   4. Urinalysis: Urine protein \\\u003C2+; if ≥2+, 24-hour urine protein must be ≤1g;\n   5. Thyroid function:TSH ≤1×ULN; if abnormal, normal T3\u002FT4 levels required for eligibility.\n8. Women of childbearing potential must:\n\n   1. Have a negative serum pregnancy test within 7 days before treatment;\n   2. Use highly effective contraception during the study and for 180 days after the last dose.\n9. Voluntarily sign informed consent, demonstrate good compliance, and commit to follow-up.\n\nExclusion Criteria:\n\n1. Inflammatory Breast Cancer.\n2. Comorbidities\u002FMedical History:\n\n   1. Autoimmune disease: patients with any known or suspected autoimmune disease, except: hypothyroidism due to autoimmune thyroiditis managed with hormone replacement therapy only, stable type-1 diabetes with well-controlled blood glucose.\n   2. Cardiovascular Diseases: poorly controlled hypertension despite medication (SBP \\>140 mmHg or DBP\\>90 mmHg). And with the history (within 6 months prior to enrollment) of myocardial infarction, severe\u002Funstable angina, NYHA Class ≥2 heart failure, clinically significant arrhythmias as well as symptomatic congestive heart failure.\n   3. Interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia);\n   4. Vaccination: receipt of live attenuated vaccines within 28 days prior to enrollment or planned during the study;\n   5. Infections: HIV\u002FAIDS, active hepatitis(HBV-DNA ≥500 IU\u002FmL; HCV-RNA above detection limit), or co-infection with HBV and HCV, severe infections within 4 weeks prior to enrollment (e.g., bacteremia, severe pneumonia requiring hospitalization), active infection requiring systemic antibiotics (CTCAE≥Grade 2) within 2 weeks prior to treatment, active tuberculosis within 1 year prior to enrollment;\n   6. Unexplained fever \\>38.5°C during screening (unless deemed tumor-related by the investigator);\n   7. Malignancy History: other malignancies diagnosed within 5 years prior to enrollment (except adequately treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ);\n   8. Surgery:Major surgery within 28 days prior to enrollment (diagnostic biopsies or PICC line placement are allowed);\n   9. Transplant: Prior or planned allogeneic bone marrow or solid organ transplant;\n   10. Neurological: peripheral neuropathy ≥Grade 2;\n   11. Gastrointestinal: clinically significant bowel obstruction;\n   12. Thrombotic Events: arterial\u002Fvenous thrombosis within 6 months prior to enrollment (e.g., stroke, transient ischemic attack, DVT, pulmonary embolism);\n   13. Bleeding Risk: hemoptysis (≥2.5 mL\u002Fday) within 2 months prior to enrollment, clinically significant bleeding within 3 months prior to enrollment (e.g. gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood≥++), and the known bleeding\u002Fthrombotic disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism);\n   14. Coagulation abnormalities (INR \\>1.5×ULN or APTT \\>1.5×ULN), or requiring long-term anticoagulation (warfarin\u002Fheparin) or antiplatelet therapy (aspirin≥300 mg\u002Fday or clopidogrel ≥75 mg\u002Fday).\n3. Treatment-Related Exclusions:\n\n   1. Prior systemic targeted therapy or immunostimulants (e.g., interferon, IL-2) within 4 weeks before treatment;\n   2. Known allergy to the investigational drug (recombinant humanized anti-PD-1 mAb) or its excipients.\n4. Clinical Trial Participation: participation in another drug trial within 4 weeks prior to enrollment, or within 5 half-lives of the last investigational drug dose.\n5. Substance Abuse: history of drug\u002Falcohol abuse or dependency.\n6. Pregnancy\u002FLactation: pregnant, breastfeeding, or planning pregnancy during the study.\n7. Investigator' s Discretion: other conditions that may compromise subject safety or study integrity (e.g., severe lab abnormalities, social factors).","FEMALE","18 Years","75 Years",{"count":98,"type":99},27,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with immunotherapy in patients with previously untreated stage IIB-IIIC (cT3N0 or cT2-4N1-3) HR-positive and HER2-negative breast cancer. 27 enrolled patients will be assigned to receive stereotactic body radiotherapy followed by Nab-Paclitaxel combined with Toripalimab. The main question it aims th answer is that whether the combination therapy of radiotherapy, de-escalated chemotherapy, and immunotherapy could improve the pCR rate of HR-positive and HER2-negative breast cancer.",[105],"Breast Cancer",[105,107],"Neoadjuvant therapy","2026-06-21",{"date":110,"type":111},"2026-06-23","ACTUAL",{"date":113,"type":111},"2025-06-05",{"date":115,"type":99},"2030-12",{"name":5,"class":6},2]