Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
Study NCT ID:
NCT05555706
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2022-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)(phase Ⅱ)', 'timeFrame': 'Baseline up to approximately 18 months', 'description': 'tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.'}, {'measure': 'Progression-free survival (PFS)(IRC) (phase Ⅲ)', 'timeFrame': 'Baseline up to approximately 18 months', 'description': 'from the start date of study treatment to the date of progression disease or death , whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'Disease control rate (DCR)', 'timeFrame': '18 months', 'description': 'DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease'}, {'measure': 'Duration of remission (DOR)', 'timeFrame': '18 months', 'description': 'DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause'}, {'measure': 'Time to Response (TTR)', 'timeFrame': '18 months', 'description': 'Defined as the interval from the start of study therapy to the first documentation of an objective response'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '3years', 'description': 'Determination of the overall survival times of all patients'}, {'measure': 'Drug concentration in plasma', 'timeFrame': '18 months', 'description': 'Determination of drug concentration in plasma of all patients'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '3years', 'description': 'Adverse event type, incidence, duration, correlation with study drug'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Triple Negative Breast Cancer (TNBC)']}, 'descriptionModule': {'briefSummary': 'This Phase II/III study assessed the efficacy, safety, pharmacokinetics, and immunogenicity of B013 administered with nab-paclitaxel in participants with locally advanced or metastatic triple negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women or men aged 18 -75 years\n2. Locally advanced or metastatic triple negative breast cancer (TNBC)\n3. No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC\n4. ECOG performance status of 0 or 1\n5. Patient must have measurable or evaluable disease as defined by RECIST v1.1. Measurable lesions will be confirmed by radiographic imaging (CT or MRI)\n\nExclusion Criteria:\n\n1. Previous treatment is eligible.\n2. Spinal cord compression not definitively treated with surgery and/or radiation prior to study entry\n3. Known central nervous system (CNS) disease\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites Patients\n5. Uncontrolled tumor-related pain prior to study entry\n6. The patient has a history of another malignancy within 5 years prior to study entry, except adequately treated non-melanotic skin cancer, carcinoma in situ of the cervix or Papillary carcinoma of the thyroid\n7. Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT05555706', 'briefTitle': 'Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Jiaolian Drug Research and Development Co., Ltd'}, 'officialTitle': 'A Phase II/III Study to Evaluate the Efficacy and Safety of B013 in Combination With Nab-Paclitaxel in First-line Treatment for Patients With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'B013-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B013+ Nab-Paclitaxel', 'description': 'B013 at a fixed dose of 600 milligrams via intravenous (IV) infusion on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.\n\nNab-Paclitaxel 100 mg/m\\^2 is administered weekly on Days 1, 8, 15 of each 28-day cycle.', 'interventionNames': ['Drug: B013+Nab-Paclitaxel']}], 'interventions': [{'name': 'B013+Nab-Paclitaxel', 'type': 'DRUG', 'description': 'B013 at a fixed dose of 600 milligrams via intravenous (IV) infusion on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.\n\nNab-Paclitaxel 100 mg/m\\^2 is administered weekly on Days 1, 8, 15 of each 28-day cycle.', 'armGroupLabels': ['B013+ Nab-Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Affiliated Cancer Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Guangxi Medical University Cancer Hospital', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '570312', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Hainan cancer Hospital', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'zip': '450062', 'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of henan University of Science and Technoloy', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '441021', 'city': 'Xiangyang', 'state': 'Hubei', 'country': 'China', 'facility': 'Xiangyang Central Hospital', 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}, {'zip': '425002', 'city': 'Yongzhou', 'state': 'Hunan', 'country': 'China', 'facility': 'The Central Hospital of Yongzhou', 'geoPoint': {'lat': 26.42389, 'lon': 111.61306}}, {'zip': '223300', 'city': "Huai'an", 'state': 'Jiangsu', 'country': 'China', 'facility': "Huai'an First People's Hospital", 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Sichuan Cancer Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '641199', 'city': 'Neijiang', 'state': 'Sichuan', 'country': 'China', 'facility': "The second people's hospital of neijiang", 'geoPoint': {'lat': 29.58354, 'lon': 105.06216}}, {'zip': '650118', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Yunnan Cancer Hospital', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '310005', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100142', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '300060', 'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin medical university cancer institute&hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Shusen Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Cancer Hospital, Sun Yat-sen University'}, {'name': 'Huiping Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiaolian Drug Research and Development Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shanghai Pharmaceuticals Holding Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}