<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04405505</url>
  </required_header>
  <id_info>
    <org_study_id>TQB2450-III-06</org_study_id>
    <nct_id>NCT04405505</nct_id>
  </id_info>
  <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)</brief_title>
  <official_title>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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized, positive parallel controlled, multicentre phase III clinical&#xD;
      trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus&#xD;
      paclitaxel for injection (albumin bound) in subjects with advanced triple negative breast&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression free survival (PFS) evaluated by Independent Review Committee(IRC)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>Percentage of participants achieving complete response (CR) and partial response (PR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate（DCR）</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">332</enrollment>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>TQB2450 + Anlotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paclitaxel for injection (albumin bound)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paclitaxel for Injection (albumin bound) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TQB2450</intervention_name>
    <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.</description>
    <arm_group_label>TQB2450 + Anlotinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anlotinib</intervention_name>
    <description>a multi-target receptor tyrosine kinase inhibitor.</description>
    <arm_group_label>TQB2450 + Anlotinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel for Injection (albumin bound)</intervention_name>
    <description>a anti-microtubule drug.</description>
    <arm_group_label>Paclitaxel for injection (albumin bound)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life&#xD;
             expectancy ≥ 3 months.&#xD;
&#xD;
             2.Histologically confirmed triple negative breast cancer. 3.Has at least one&#xD;
             measurable lesion. 4.Newly diagnosed stage IV or recurrent/metastatic triple negative&#xD;
             breast cancer who are not suitable for surgery.&#xD;
&#xD;
             5.Prior local radiotherapy for metastatic sites is allowed. 6.Adequate laboratory&#xD;
             indicators. 7.Understood and signed an informed consent form. 8.No pregnant or&#xD;
             breastfeeding women, and a negative pregnancy test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Has received anti-angiogenic drugs or other PD-1 / PD-L1 / CTLA-4 antibody therapy&#xD;
             or other immunotherapy against PD-1 / PD-L1 / CTLA-4.&#xD;
&#xD;
             2. Severe hypersensitivity occurs after administration of other monoclonal antibodies.&#xD;
&#xD;
             3. Has other malignancies (except cured skin basal cell carcinoma and cervical&#xD;
             carcinoma in situ) within 3 years.&#xD;
&#xD;
             4. Has any active autoimmune disease or history of autoimmune disease. 5. Has a clear&#xD;
             clinical diagnosis of interstitial pneumonia, pulmonary fibrosis, drug-induced&#xD;
             pneumonia, or active pneumonia.&#xD;
&#xD;
             6. Peripheral neuropathy ≥ grade 2. 7. Immunosuppressant or systemic or absorbable&#xD;
             local hormone therapy is required to achieve the aim of immunosuppression (dose &amp;gt;&#xD;
             10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks&#xD;
             after the first administration.&#xD;
&#xD;
             8. Has multiple factors affecting oral medication. 9. Has uncontrolled and repeated&#xD;
             drainage pleural effusion, pericardial effusion, and ascites.&#xD;
&#xD;
             10. Has any signs of bleeding or history. 11. Has unrelieved spinal cord compression.&#xD;
             12. Has symptomatic central nervous system (CNS) disease and / or cancerous&#xD;
             meningitis, pia mater disease.&#xD;
&#xD;
             13. Has received other anti-tumor therapy within 4 weeks before the first&#xD;
             administration.&#xD;
&#xD;
             14. Has any serious and/or uncontrollable disease. 15. Has received vaccination or&#xD;
             attenuated vaccine within 4 weeks before the first administration.&#xD;
&#xD;
             16. According to the judgement of the investigators, there are other factors that may&#xD;
             lead to the termination of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Binghe Xu, Doctor</last_name>
    <phone>010-87788826</phone>
    <email>xubinghe@medmail.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Fourth Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230022</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yunhong Xia, Doctor</last_name>
      <email>yhxia@sina.com</email>
    </contact>
    <investigator>
      <last_name>Yunhong Xia, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciencesand Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Hongyan Ying, Doctor</last_name>
      <email>yinghy15@163.com</email>
    </contact>
    <investigator>
      <last_name>Hongyan Ying, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Shijitan Hospital Affiliated to Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100038</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jun Ren, Doctor</last_name>
      <email>jun.ren@duke.edu</email>
    </contact>
    <investigator>
      <last_name>Jun Ren, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Tsinghua Changgung Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>102218</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Bin Luo, Doctor</last_name>
      <email>luobin@mail.tsinghua.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Bin Luo, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Binghe Xu, Doctor</last_name>
      <phone>010-87788826</phone>
      <email>xubinghe@medmail.com.cn</email>
    </contact>
    <investigator>
      <last_name>Binghe Xu, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chongqing Cancer Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xiaohua Zeng, Doctor</last_name>
      <email>1340110079@qq.com</email>
    </contact>
    <investigator>
      <last_name>Xiaohua Zeng, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affilited Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Lu Gan, Doctor</last_name>
      <email>ganlu99@sina.com</email>
    </contact>
    <investigator>
      <last_name>Lu Gan, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510030</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Ning Liao, Doctor</last_name>
      <email>drningliao@163.com</email>
    </contact>
    <investigator>
      <last_name>Ning Liao, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Guangxi Medical University Affiliated Tumor Hospital</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi Zhuang Autonomous Region</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Wenxian Zhou, Doctor</last_name>
      <email>939935994@qq.com</email>
    </contact>
    <investigator>
      <last_name>Wenxian Zhou, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi Zhuang Autonomous Region</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jincai Zhong, Master</last_name>
    </contact>
    <investigator>
      <last_name>Jincai Zhong, Master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050010</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Cuizhi Geng, Doctor</last_name>
      <email>gengcuizhi@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Cuizhi Geng, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Affiliated Tumor Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Qingyuan Zhang, Doctor</last_name>
      <email>sy86298276@163.com</email>
    </contact>
    <investigator>
      <last_name>Qingyuan Zhang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AnYang Tumor Hospital</name>
      <address>
        <city>Anyang</city>
        <state>Henan</state>
        <zip>455000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jing Sun</last_name>
    </contact>
    <investigator>
      <last_name>Jing Sun</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430061</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yahua Zhong, Doctor</last_name>
      <email>doctorzyh73@163.com</email>
    </contact>
    <investigator>
      <last_name>Yahua Zhong, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Quchang Ouyang, Doctor</last_name>
      <email>oyqc1969@126.com</email>
    </contact>
    <investigator>
      <last_name>Quchang Ouyang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nantong Tumor Hospital</name>
      <address>
        <city>Nantong</city>
        <state>Jiangsu</state>
        <zip>226000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Bojian Ge</last_name>
      <email>doctorge@126.com</email>
    </contact>
    <investigator>
      <last_name>Bojian Ge</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Wei Li, Doctor</last_name>
      <email>jdyylw@163.com</email>
    </contact>
    <investigator>
      <last_name>Wei Li, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yanbian University Hospital</name>
      <address>
        <city>Yanji</city>
        <state>Jilin</state>
        <zip>133000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Songnan Zhang, Doctor</last_name>
      <email>zhangsn21@163.com</email>
    </contact>
    <investigator>
      <last_name>Songnan Zhang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110011</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yuee Teng, Doctor</last_name>
      <phone>024-83282543</phone>
      <email>tengyuee517@yahoo.com.cn</email>
    </contact>
    <investigator>
      <last_name>Yuee Teng, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110042</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Tao Sun, Doctor</last_name>
      <email>lnzlrxnsy@163.com</email>
    </contact>
    <investigator>
      <last_name>Tao Sun, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xiuwen Wang, Doctor</last_name>
      <email>wangxiuwen@csco.org.cn</email>
    </contact>
    <investigator>
      <last_name>Xiuwen Wang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanxi Cancer Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030013</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Fuguo Tian, Master</last_name>
      <email>2205473988@qq.com</email>
    </contact>
    <investigator>
      <last_name>Fuguo Tian, Master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of PLA Airforce Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Huadong Zhao, Doctor</last_name>
      <email>zhaolujy@fmmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Huadong Zhao, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yu Ren, Doctor</last_name>
      <email>renyyyyy@126.com</email>
    </contact>
    <investigator>
      <last_name>Yu Ren, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanxi Provincial People's Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710068</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second People's Hospital of Neijiang</name>
      <address>
        <city>Neijiang</city>
        <state>Sichuan</state>
        <zip>641100</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xujuan Wang, Master</last_name>
      <email>61132803@qq.com</email>
    </contact>
    <investigator>
      <last_name>Xujuan Wang, Master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Zhongsheng Tong</last_name>
    </contact>
    <investigator>
      <last_name>Zhongsheng Tong</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xinjiang Uiger Municipal People's Hospital</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang</state>
        <zip>830000</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Pengcheng Su, Master</last_name>
      <email>drsupengcheng@163.com</email>
    </contact>
    <investigator>
      <last_name>Pengcheng Su, Master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xiaojia Wang, Doctor</last_name>
      <email>wxiaojia0803@163.com</email>
    </contact>
    <investigator>
      <last_name>Xiaojia Wang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310052</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Fuming Qiu, Doctor</last_name>
      <email>qiufuming@zju.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Fuming Qiu, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 24, 2020</last_update_submitted>
  <last_update_submitted_qc>May 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04405505
org study id: TQB2450-III-06
nct id: NCT04405505
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
time frame: 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.
measure: Overall response rate (ORR)
time frame: up to 96 weeks
description: Percentage of participants achieving complete response (CR) and partial response (PR).
measure: Disease control rate（DCR）
time frame: 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)
time frame: 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.
arm group label: TQB2450 + Anlotinib
arm group type: Experimental
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).
arm group label: Paclitaxel for injection (albumin bound)
arm group type: Active Comparator
description: Paclitaxel for Injection (albumin bound) 100mg / m2 administered intravenously (IV) on Day 1, 8, 15 in 28-day cycle.
intervention type: Drug
intervention name: TQB2450
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.
arm group label: TQB2450 + Anlotinib
intervention type: Drug
intervention name: Anlotinib
description: a multi-target receptor tyrosine kinase inhibitor.
arm group label: TQB2450 + Anlotinib
intervention type: Drug
intervention name: Paclitaxel for Injection (albumin bound)
description: a anti-microtubule drug.
arm group label: Paclitaxel for injection (albumin bound)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Binghe Xu, Doctor
phone: 010-87788826
email: xubinghe@medmail.com.cn
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country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Paclitaxel