Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-22 @ 2:53 AM
Study NCT ID:
NCT04405505
Status:
UNKNOWN
Last Update Posted:
2020-05-28
First Post:
2020-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)
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': 'C000625192', 'term': 'anlotinib'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 332}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-24', 'studyFirstSubmitDate': '2020-05-24', 'studyFirstSubmitQcDate': '2020-05-24', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS) evaluated by Independent Review Committee(IRC)', 'timeFrame': 'up to 96 weeks', 'description': 'PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': 'up to 96 weeks', 'description': 'Percentage of participants achieving complete response (CR) and partial response (PR).'}, {'measure': 'Disease control rate（DCR）', 'timeFrame': 'up to 96 weeks', 'description': 'Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'up to 96 weeks', 'description': 'DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Triple Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus paclitaxel for injection (albumin bound) in subjects with advanced triple negative breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.\n\n 2.Histologically confirmed triple negative breast cancer. 3.Has at least one measurable lesion. 4.Newly diagnosed stage IV or recurrent/metastatic triple negative breast cancer who are not suitable for surgery.\n\n 5.Prior local radiotherapy for metastatic sites is allowed. 6.Adequate laboratory indicators. 7.Understood and signed an informed consent form. 8.No pregnant or breastfeeding women, and a negative pregnancy test.\n\nExclusion Criteria:\n\n* 1.Has received anti-angiogenic drugs or other PD-1 / PD-L1 / CTLA-4 antibody therapy or other immunotherapy against PD-1 / PD-L1 / CTLA-4.\n\n 2\\. Severe hypersensitivity occurs after administration of other monoclonal antibodies.\n\n 3\\. Has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years.\n\n 4\\. Has any active autoimmune disease or history of autoimmune disease. 5. Has a clear clinical diagnosis of interstitial pneumonia, pulmonary fibrosis, drug-induced pneumonia, or active pneumonia.\n\n 6\\. Peripheral neuropathy ≥ grade 2. 7. Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose \\> 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration.\n\n 8\\. Has multiple factors affecting oral medication. 9. Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites.\n\n 10\\. Has any signs of bleeding or history. 11. Has unrelieved spinal cord compression. 12. Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease.\n\n 13\\. Has received other anti-tumor therapy within 4 weeks before the first administration.\n\n 14\\. Has any serious and/or uncontrollable disease. 15. Has received vaccination or attenuated vaccine within 4 weeks before the first administration.\n\n 16\\. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.'}, 'identificationModule': {'nctId': 'NCT04405505', 'briefTitle': 'A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Paclitaxel for Injection (Albumin Bound) in Subjects With Triple Negative Breast Cancer (TNBC)', 'orgStudyIdInfo': {'id': 'TQB2450-III-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQB2450 + Anlotinib', 'description': 'TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).', 'interventionNames': ['Drug: TQB2450', 'Drug: Anlotinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paclitaxel for injection (albumin bound)', 'description': 'Paclitaxel for Injection (albumin bound) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle.', 'interventionNames': ['Drug: Paclitaxel for Injection (albumin bound)']}], 'interventions': [{'name': 'TQB2450', 'type': 'DRUG', 'description': 'TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.', 'armGroupLabels': ['TQB2450 + Anlotinib']}, {'name': 'Anlotinib', 'type': 'DRUG', 'description': 'a multi-target receptor tyrosine kinase inhibitor.', 'armGroupLabels': ['TQB2450 + Anlotinib']}, {'name': 'Paclitaxel for Injection (albumin bound)', 'type': 'DRUG', 'description': 'a anti-microtubule drug.', 'armGroupLabels': ['Paclitaxel for injection (albumin bound)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230022', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'contacts': [{'name': 'Yunhong Xia, Doctor', 'role': 'CONTACT', 'email': 'yhxia@sina.com'}, {'name': 'Yunhong Xia, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Fourth Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Hongyan Ying, Doctor', 'role': 'CONTACT', 'email': 'yinghy15@163.com'}, {'name': 'Hongyan Ying, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese Academy of Medical Sciencesand Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100038', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Jun Ren, Doctor', 'role': 'CONTACT', 'email': 'jun.ren@duke.edu'}, {'name': 'Jun Ren, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Shijitan Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '102218', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Bin Luo, Doctor', 'role': 'CONTACT', 'email': 'luobin@mail.tsinghua.edu.cn'}, {'name': 'Bin Luo, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tsinghua Changgung Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Binghe Xu, Doctor', 'role': 'CONTACT', 'email': 'xubinghe@medmail.com.cn', 'phone': '010-87788826'}, {'name': 'Binghe Xu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'contacts': [{'name': 'Xiaohua Zeng, Doctor', 'role': 'CONTACT', 'email': '1340110079@qq.com'}, {'name': 'Xiaohua Zeng, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chongqing Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'contacts': [{'name': 'Lu Gan, Doctor', 'role': 'CONTACT', 'email': 'ganlu99@sina.com'}, {'name': 'Lu Gan, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affilited Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '510030', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Ning Liao, Doctor', 'role': 'CONTACT', 'email': 'drningliao@163.com'}, {'name': 'Ning Liao, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'contacts': [{'name': 'Wenxian Zhou, Doctor', 'role': 'CONTACT', 'email': '939935994@qq.com'}, {'name': 'Wenxian Zhou, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangxi Medical University Affiliated Tumor Hospital', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'contacts': [{'name': 'Jincai Zhong, Master', 'role': 'CONTACT'}, {'name': 'Jincai Zhong, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '050010', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'contacts': [{'name': 'Cuizhi Geng, Doctor', 'role': 'CONTACT', 'email': 'gengcuizhi@hotmail.com'}, {'name': 'Cuizhi Geng, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The fourth Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '150000', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'contacts': [{'name': 'Qingyuan Zhang, Doctor', 'role': 'CONTACT', 'email': 'sy86298276@163.com'}, {'name': 'Qingyuan Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Tumor Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '455000', 'city': 'Anyang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Jing Sun', 'role': 'CONTACT'}, {'name': 'Jing Sun', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AnYang Tumor Hospital', 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'zip': '430061', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Yahua Zhong, Doctor', 'role': 'CONTACT', 'email': 'doctorzyh73@163.com'}, {'name': 'Yahua Zhong, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Quchang Ouyang, Doctor', 'role': 'CONTACT', 'email': 'oyqc1969@126.com'}, {'name': 'Quchang Ouyang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '226000', 'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Bojian Ge', 'role': 'CONTACT', 'email': 'doctorge@126.com'}, {'name': 'Bojian Ge', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nantong Tumor Hospital', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'contacts': [{'name': 'Wei Li, Doctor', 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'China', 'contacts': [{'name': 'Tao Sun, Doctor', 'role': 'CONTACT', 'email': 'lnzlrxnsy@163.com'}, {'name': 'Tao Sun, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Liaoning Cancer Hospital & Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Xiuwen Wang, Doctor', 'role': 'CONTACT', 'email': 'wangxiuwen@csco.org.cn'}, {'name': 'Xiuwen Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '030013', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'contacts': [{'name': 'Fuguo Tian, Master', 'role': 'CONTACT', 'email': '2205473988@qq.com'}, {'name': 'Fuguo Tian, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanxi Cancer Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'contacts': [{'name': 'Huadong Zhao, Doctor', 'role': 'CONTACT', 'email': 'zhaolujy@fmmu.edu.cn'}, {'name': 'Huadong Zhao, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of PLA Airforce Military Medical University', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '710061', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'contacts': [{'name': 'Yu Ren, Doctor', 'role': 'CONTACT', 'email': 'renyyyyy@126.com'}, {'name': 'Yu Ren, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '710068', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': "Shanxi Provincial People's Hospital", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '641100', 'city': 'Neijiang', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Xujuan Wang, Master', 'role': 'CONTACT', 'email': '61132803@qq.com'}, {'name': 'Xujuan Wang, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Second People's Hospital of Neijiang", 'geoPoint': {'lat': 29.58354, 'lon': 105.06216}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'Zhongsheng Tong', 'role': 'CONTACT'}, {'name': 'Zhongsheng Tong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '830000', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'contacts': [{'name': 'Pengcheng Su, Master', 'role': 'CONTACT', 'email': 'drsupengcheng@163.com'}, {'name': 'Pengcheng Su, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Xinjiang Uiger Municipal People's Hospital", 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Xiaojia Wang, Doctor', 'role': 'CONTACT', 'email': 'wxiaojia0803@163.com'}, {'name': 'Xiaojia Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310052', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Fuming Qiu, Doctor', 'role': 'CONTACT', 'email': 'qiufuming@zju.edu.cn'}, {'name': 'Fuming Qiu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Binghe Xu, Doctor', 'role': 'CONTACT', 'email': 'xubinghe@medmail.com.cn', 'phone': '010-87788826'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}