Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2026-01-04 @ 6:01 PM
Study NCT ID:
NCT06691594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-20
First Post:
2024-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy', 'timeFrame': 'From enrollment to the completion of surgery', 'description': 'pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoperative radiothrapy', 'immunotherapy', 'triple-negative breast cancer'], 'conditions': ['Breast Cancer Invasive']}, 'descriptionModule': {'briefSummary': 'The primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. This is a single-arm study. Eligible participants will receive : neoadjuvant treatment consisting of SBRT followed by Envafolimab (PD-1 inhibitor), chemotherapy and immunotherapy (Envafolimab). Surgery will be performed after the last chemotherapy cycle. Pathological evaluation will assess the treatment response. Patients will receive adjuvant immunotherapy (Envafolimab) up to 1 year post-surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nSigned written informed consent prior to enrollment\n\nAge ≥ 18 years\n\nECOG PS score 0-1\n\nNewly diagnosed T1c N1-2 or T2-3 N0-2 breast cancer\n\nTriple-negative breast cancer with PD-L1 CPS \\< 10\n\nHemoglobin ≥ 10.0 g/dl, neutrophils ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L\n\nBUN ≤ 1.5 × upper limit of normal (ULN), creatinine ≤ 1.5 × ULN\n\nSerum bilirubin ≤ 1.5 × ULN, alkaline phosphatase (AKP), AST, and ALT ≤ 2.5 × ULN\n\nWomen of childbearing potential must be willing to use contraception during the study\n\nNegative serum or urine pregnancy test within 7 days prior to treatment\n\nExclusion Criteria\n\nOccult breast cancer\n\nBilateral breast cancer\n\nBreast tumor unsuitable for SBRT\n\nUnable to undergo MRI scanning\n\nHistory of other malignancies that may affect survival\n\nActive autoimmune disease or history of autoimmune disease\n\nCurrent use of immunosuppressants or systemic steroids (within 2 weeks prior to enrollment)\n\nKnown allergy to any component of the investigational drugs\n\nUncontrolled cardiac symptoms or diseases\n\nActive infection or unexplained fever \\> 38.5°C during screening/before first dose\n\nOther factors likely to cause early study termination (e.g., serious concurrent illnesses, significant lab abnormalities, or social/family circumstances affecting safety/data collection)'}, 'identificationModule': {'nctId': 'NCT06691594', 'briefTitle': 'Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Prospective, Single-arm, Phase II Study of Stereotactic Radiotherapy Combined with PD-1 Monoclonal Antibody and Chemotherapy As Neoadjuvant Treatment for Triple-negative Breast Cancer', 'orgStudyIdInfo': {'id': 'NCC4456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy', 'description': 'Eligible participants will receive neoadjuvant treatment consisting of:\n\nSBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor).\n\nChemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5).\n\nSurgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response.\n\nAdjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year.', 'interventionNames': ['Radiation: neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy']}], 'interventions': [{'name': 'neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy', 'type': 'RADIATION', 'otherNames': ['radiotherapy combined with chemotherapy and immunotherapy'], 'description': 'Eligible participants will receive neoadjuvant treatment consisting of:\n\nSBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor).\n\nChemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5).\n\nSurgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response.\n\nAdjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year.', 'armGroupLabels': ['neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xuran Zhao, Doctor', 'role': 'CONTACT', 'email': '923791362@qq.com', 'phone': '13661135602'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shulian Wang', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}