Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-31 @ 9:02 AM
Study NCT ID:
NCT05909332
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative 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': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 548}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2031-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-17', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-06-11', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'iDFS', 'timeFrame': '5 years', 'description': 'invasive disease-free survival'}], 'secondaryOutcomes': [{'measure': 'DRFS', 'timeFrame': '5 years', 'description': 'distant recurrence free survival'}, {'measure': 'OS', 'timeFrame': '5 years', 'description': 'overall survival'}, {'measure': 'AE', 'timeFrame': '5 years', 'description': 'adverse effects'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['triple negative breast cancer', 'adjuvant therapy', 'antivascular therapy'], 'conditions': ['Breast Cancer', 'Triple Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label phase III clinical trial comparing antivascular therapy combined with standard chemotherapy and standard chemotherapy in adjuvant therapy for patients with triple-negative breast cancer, basal-like/Immune suppressed subtype.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-70 years old;\n* Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1;\n* Histological results recorded as TNBC (negative HER2, ER, and PgR status) and BLIS subtype according to the classification of FUSCC;\n* Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0;\n* Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (ANC) ≥ 1500 cells/μL (no G-CSF support therapy within 2 weeks prior to day 1 of course 1); Platelet count ≥ 75×109/L (no platelet transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dL (no RBC transfusion within 2 weeks before day 1 of course 1); AST, ALT, and alkaline phosphatase ≤ 3 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; serum creatinine ≤ 1ULN and with an endogenous creatinine clearance rate of \\>50 ml/min (Cockcroft-Gault formula);\n* The surgical incision had fully healed prior to the commencement of the study;\n* Female participants of reproductive potential are required to use a medically accepted form of contraception during the course of the study treatment and for at least three months following the last administration of the investigational drug;\n* Sign the Informed Consent Form (ICF). The patient is judged by the investigator to have the ability to comply with the provisions of the protocol.\n\nExclusion Criteria:\n\n* Has received neoadjuvant therapy (including chemotherapy, targeted therapy, and radiotherapy)\n* Has bilateral breast cancer;\n* Has a previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.\n* Has metastatic (Stage 4) breast cancer;\n* Has any \\>T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer);\n* Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \\< 50% (a cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous to randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;\n* Is pregnant, breastfeeding women, or women of childbearing age who cannot practice effective contraceptives;\n* Patients participating in other clinical trials at the same time;\n* Has known allergy to taxane and excipients.\n* Has severe or uncontrolled infection;\n* Has a history of psychotropic substance abuse and was unable to abandon drug habits or those with a history of mental disorders;\n* the researchers judged patients to be unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT05909332', 'briefTitle': 'Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03)', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Randomized, Open-label Phase III Clinical Trial Comparing Antivascular Therapy Combined With Standard Chemotherapy and Standard Chemotherapy in Adjuvant Therapy for Patients With Triple-Negative Breast Cancer, Basal-like Immunosuppressed Subtype (BCTOP-T-A03)', 'orgStudyIdInfo': {'id': 'BCTOP-T-A03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm-A', 'description': 'BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W + Chemotherapy ddEC-P(described below). This was followed by maintenance therapy with BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W to complete treatment with a total duration of 1 year from the first dose.\n\nChemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks.', 'interventionNames': ['Drug: Antivascular therapy', 'Drug: Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm-B', 'description': 'Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks.', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Antivascular therapy', 'type': 'DRUG', 'description': 'BP102 (anti VEGFR)', 'armGroupLabels': ['Arm-A']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'ddEC-P', 'armGroupLabels': ['Arm-A', 'Arm-B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'HuiPing Li, MD', 'role': 'CONTACT', 'phone': '+86-010-88121122'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaohua Zeng, MD', 'role': 'CONTACT', 'phone': '+86-023-65311341'}], 'facility': 'Chongqing Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ChuanGui Song, MD', 'role': 'CONTACT', 'phone': '+86-591-83357896'}], 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kun Wang, MD', 'role': 'CONTACT', 'phone': '+86-020-83827812'}], 'facility': "Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510062', 'city': 'Guangdong', 'state': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ShuSen Wang, MD', 'role': 'CONTACT', 'phone': '+86-020-87343292'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 42.76832, 'lon': 129.33635}}, {'zip': '226006', 'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ZhiXian He, MD', 'role': 'CONTACT', 'phone': '+86-513-85052504'}, {'name': 'SuJie Ni, MD', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '225009', 'city': 'Yangzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'DeYuan Fu, MD', 'role': 'CONTACT', 'phone': '+86-0514-87373114'}], 'facility': "Northern Jiangsu People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'zip': '110002', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YueE Teng, MD', 'role': 'CONTACT', 'phone': '+86-024-83283333'}, {'name': 'YingYing Xu, MD', 'role': 'CONTACT'}], 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110801', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Shen, MD', 'role': 'CONTACT', 'phone': '+86-024-81916684'}, {'name': 'Qiang Zhang, MD', 'role': 'CONTACT'}], 'facility': 'Liaoning Cancer Hospital & Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhi-Ming Shao, MD', 'role': 'CONTACT', 'email': 'zhimingshao@yahoo.com', 'phone': '86-21-641755901105'}, {'name': 'Lei Fan, MD', 'role': 'CONTACT', 'email': 'cmchen@medmail.com.cn', 'phone': '86-21-641755901105'}, {'name': 'Zhi-Ming Shao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Min He, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Linxiaoxi Ma, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ying Zhou', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Breast cancer institute of Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200233', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zan Shen, MD', 'role': 'CONTACT', 'phone': '+86-021-64369181'}], 'facility': "Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201204', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ZhiGang Zhuang, MD', 'role': 'CONTACT', 'phone': '+86-021-20261000'}], 'facility': 'Shanghai First Maternity and Infant Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710061', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Yang, MD', 'role': 'CONTACT', 'phone': '+86-029-85323217'}], 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Luo, MD', 'role': 'CONTACT', 'phone': '+86-028-85422114'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'WeiZhu Wu, MD', 'role': 'CONTACT', 'phone': '+86-574-87018701'}], 'facility': 'Ningbo Medical Center Lihuili Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'centralContacts': [{'name': 'Zhi-Ming Shao, MD, PhD', 'role': 'CONTACT', 'email': 'zhimingshao@yahoo.com', 'phone': '+86-021-64175590', 'phoneExt': '8808'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of General Surgery of Fudan Shanghai Cancer Center', 'investigatorFullName': 'Zhimin Shao', 'investigatorAffiliation': 'Fudan University'}}}}