Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:15 PM
Study NCT ID:
NCT07410234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Exploratory Study of Toripalimab Combined With SBRT in HER2-Negative Breast Cancer Patients With Insensitivity to Neoadjuvant Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656314', 'term': 'toripalimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-02-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-08', 'studyFirstSubmitDate': '2026-02-08', 'studyFirstSubmitQcDate': '2026-02-08', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic complete response（pCR）', 'timeFrame': 'Up to12 months', 'description': 'pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab combined with radiochemotherapy as perioperative therapy in HER2-negative breast cancer patients insensitive to neoadjuvant chemotherapy.\n\nThis was a multicohort, single-center exploratory clinical study. Eligible patients were initially administered standard neoadjuvant chemotherapy (TAC or TE regimen). Efficacy assessment was performed after 2 cycles of neoadjuvant chemotherapy, and only those evaluated as stable disease (SD) were formally enrolled. Enrolled patients were stratified into the HR-positive group and the triple-negative breast cancer (TNBC) group, with each group further divided into 3 arms receiving the following treatments respectively:\n\n* Cohort 1: Continued the original neoadjuvant chemotherapy for 4 cycles, followed by surgical treatment within 5 weeks for eligible patients.\n* Cohort 2: Received the original neoadjuvant chemotherapy regimen plus toripalimab for 4 cycles, followed by surgery within 5 weeks; toripalimab monotherapy was continued for an additional 13 cycles postoperatively.\n* Cohort 3: Received the original neoadjuvant chemotherapy regimen plus toripalimab for 4 cycles combined with concurrent stereotactic body radiation therapy (SBRT, 25Gy/5f), followed by surgery within 5 weeks; toripalimab monotherapy was continued for an additional 13 cycles postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient voluntarily participates in this study, has signed the informed consent form, with good compliance and willingness to cooperate with follow-up.\n* Aged ≥18 years, male or female.\n* Histologically confirmed unilateral primary invasive breast cancer, meeting the criteria of cT2-4N0-2M0.\n* HER-2 expression negative by immunohistochemistry (IHC); for patients with HER-2 2+ expression, HER-2 gene non-amplification must be confirmed by in situ hybridization (ISH).\n* Patients with stable disease (SD) assessed after 2 cycles of neoadjuvant chemotherapy.\n* At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1.\n* Expected survival ≥3 months.\n* At least one tumor tissue biopsy specimen of the primary tumor obtained during screening must be provided to the central laboratory.\n* Function of vital organs meets the following requirements (administration of any blood components or cell growth factors is not allowed within 2 weeks before the start of screening tests):\n\n 1. Absolute neutrophil count (ANC) ≥1.5×10⁹/L;\n 2. Platelet count ≥100×10⁹/L;\n 3. Hemoglobin ≥9 g/dL;\n 4. Serum albumin ≥3.0 g/dL;\n 5. Total bilirubin ≤1.5×upper limit of normal (ULN), alanine transaminase (ALT) and/or aspartate transaminase (AST) ≤2.5×ULN;\n 6. Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (calculated according to the Cockcroft-Gault formula);\n 7. International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN (screening is permitted for patients receiving stable-dose anticoagulant therapy \\[e.g., low-molecular-weight heparin or warfarin\\] with INR within the expected therapeutic range for the anticoagulant).\n* Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 72 hours prior to the first administration of the study drug with a negative result, and agree to use an effective contraceptive method during the trial and for 6 months after the last dose. Male subjects whose partners are women of childbearing potential must use an effective contraceptive method during the trial and for 6 months after the last dose.\n\nExclusion Criteria:\n\n* A history of invasive malignancy within 5 years prior to signing the informed consent form, except for adequately treated basal/squamous cell skin cancer or carcinoma in situ of the cervix.\n* Receipt of any of the following treatments:\n\n 1. Major surgery or severe trauma within 4 weeks prior to the first dose of study drug;\n 2. Receipt of any non-neoadjuvant anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biotherapy, or tumor embolization) within 12 months prior to the first dose of study drug;\n 3. Previous vaccination with anti-tumor vaccine, or vaccination with live vaccine within 4 weeks prior to the first dose of study drug;\n 4. Requirement for systemic therapy with corticosteroids (\\>10 mg prednisone equivalent per day) or other immunosuppressants within 2 weeks prior to the first dose of study drug.\n* A current or historical diagnosis of any active autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); excluding vitiligo, or patients with childhood asthma/allergies that have resolved and require no intervention in adulthood. Patients with autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement hormone and patients with type 1 diabetes on a stable dose of insulin are eligible for enrollment.\n* A history of immunodeficiency, including positive HIV test results, other acquired/congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.\n* Uncontrolled clinical cardiac symptoms or diseases, including: (1) heart failure of NYHA Class Ⅱ or higher; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular/ventricular arrhythmias requiring clinical intervention.\n* Severe infection (CTCAE Grade \\>2) within 4 weeks prior to the first dose of study drug (e.g., severe pneumonia, bacteremia, infectious complications requiring hospitalization); active pulmonary inflammation indicated by baseline chest imaging; signs and symptoms of infection requiring oral/intravenous antibiotic therapy within 2 weeks prior to the first dose of study drug (prophylactic antibiotic use is excluded); active pulmonary tuberculosis confirmed by medical history or CT scan, a history of active pulmonary tuberculosis within 1 year prior to enrollment, or a history of active pulmonary tuberculosis more than 1 year prior to enrollment without standard treatment.\n* Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or active hepatitis C (positive anti-HCV antibodies with HCV-RNA above the lower limit of detection of the assay).\n* Known hypersensitivity or intolerance to toripalimab, chemotherapy drugs used in the study, or their excipients.\n* Pregnant or lactating women; subjects of childbearing potential who are unwilling or unable to adopt effective contraceptive measures.\n* Current participation in another clinical study or participation within the previous 4 weeks.\n* Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in the study."}, 'identificationModule': {'nctId': 'NCT07410234', 'briefTitle': 'Phase II Exploratory Study of Toripalimab Combined With SBRT in HER2-Negative Breast Cancer Patients With Insensitivity to Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'Phase II Exploratory Study of Toripalimab Combined With Stereotactic Body Radiation Therapy in HER2-Negative Breast Cancer Patients With Insensitivity to Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'TJCIH-TNBCTori-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HR1', 'interventionNames': ['Drug: standard neoadjuvant chemotherapy regimens']}, {'type': 'EXPERIMENTAL', 'label': 'HR2', 'interventionNames': ['Drug: Toripalimab', 'Drug: standard neoadjuvant chemotherapy regimens']}, {'type': 'EXPERIMENTAL', 'label': 'HR3', 'interventionNames': ['Drug: Toripalimab', 'Radiation: SBRT', 'Drug: standard neoadjuvant chemotherapy regimens']}, {'type': 'OTHER', 'label': 'TNBC1', 'interventionNames': ['Drug: standard neoadjuvant chemotherapy regimens']}, {'type': 'EXPERIMENTAL', 'label': 'TNBC2', 'interventionNames': ['Drug: Toripalimab', 'Drug: standard neoadjuvant chemotherapy regimens']}, {'type': 'EXPERIMENTAL', 'label': 'TNBC3', 'interventionNames': ['Drug: Toripalimab', 'Radiation: SBRT', 'Drug: standard neoadjuvant chemotherapy regimens']}], 'interventions': [{'name': 'Toripalimab', 'type': 'DRUG', 'description': 'Preoperative: toripalimab, 240mg, IV, D1, Q3W. Preoperative toripalimab contains 4 cycles.\n\nPostoperative: Toripalimab 240mg, IV, D1, Q3W. . Postoperative Toripalimab following surgery within 5 weeks for 13 cycles.', 'armGroupLabels': ['HR2', 'HR3', 'TNBC2', 'TNBC3']}, {'name': 'SBRT', 'type': 'RADIATION', 'description': 'Local radiotherapy: Subjects received concurrent stereotactic body radiotherapy (SBRT，25 Gray in 5 fractions) for the primary lesion, within 5 weeks before the surgery.', 'armGroupLabels': ['HR3', 'TNBC3']}, {'name': 'standard neoadjuvant chemotherapy regimens', 'type': 'DRUG', 'description': 'standard neoadjuvant chemotherapy regimens for breast cancer: TAC, TE, etc. T: docetaxel, nab-paclitaxel or paclitaxel. Routine clinical dosage and administration shall be adopted.\n\nA: epirubicin, pirarubicin or doxorubicin. Routine clinical dosage and administration shall be adopted.\n\nC: cyclophosphamide 500 mg/m², IV. Q3W. Dose reduction and treatment delay are permitted; the maximum allowable delay is 3 weeks, calculated from the last administration date. Treatment shall be discontinued if this limit is exceeded.\n\nE: epirubicin. Routine clinical dosage and administration shall be adopted.', 'armGroupLabels': ['HR1', 'HR2', 'HR3', 'TNBC1', 'TNBC2', 'TNBC3']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lina Zhang', 'role': 'CONTACT', 'email': 'linazhang2005@126.com', 'phone': '86-22-23359337'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}