<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/NCT04400695</url>
  </required_header>
  <id_info>
    <org_study_id>RC48-C012</org_study_id>
    <nct_id>NCT04400695</nct_id>
  </id_info>
  <brief_title>A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2</brief_title>
  <official_title>Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RemeGen Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RemeGen Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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 will compare RC48-ADC to physician choice standard treatment. Participants must&#xD;
      have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one&#xD;
      or two systemic chemotherapy regimens following recurrence/metastasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multi-center, randomized, open, parallel control to evaluate the&#xD;
      effectiveness and safety of Phase III clinical trials of the efficacy and safety of&#xD;
      recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate&#xD;
      for the treatment of locally advanced or metastatic breast cancer the study.The low&#xD;
      expression of HER2 is defined as: the immunohistochemistry (IHC) confirmed by the central&#xD;
      laboratory detects the expression of HER2 protein as IHC 2+ and the fluorescence in situ&#xD;
      hybridization (FISH) detection has no amplification.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 29, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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 an independent efficacy evaluation committee</measure>
    <time_frame>within approximately 3 years</time_frame>
    <description>Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS), evaluated by the investigator</measure>
    <time_frame>within approximately 3 years</time_frame>
    <description>Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective remission rate (ORR)</measure>
    <time_frame>within approximately 3 years</time_frame>
    <description>The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of relief (DOR)</measure>
    <time_frame>within approximately 3 years</time_frame>
    <description>DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>within approximately 3 years</time_frame>
    <description>Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor progression time (TTP)</measure>
    <time_frame>within approximately 3 years</time_frame>
    <description>Time to disease progression (TTP) refers to the time from the random date to the first disease progression (calculated by the event that occurred first). Disease progression will be evaluated by the investigator according to the RECIST 1.1 standard (investigator and Independent Review Committee(IRC) evaluation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>within approximately 3 years</time_frame>
    <description>Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">366</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>RC48-ADC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RC48-ADC common name：Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection Dosage form：Lyophilized powder injection specification：60 mg / piece Medication plan：Every 2 weeks Expiration date：18 months HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physician's Choice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physician's Choice:&#xD;
HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis.&#xD;
Physician's choice from the following options:&#xD;
Paclitaxel Injection Docetaxel Injection Vinorelbine Tartrate Injection Capecitabine Tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RC48-ADC</intervention_name>
    <description>RC48-ADC 2.0mg / kg, intravenous drip, once every 2 weeks</description>
    <arm_group_label>RC48-ADC</arm_group_label>
    <other_name>RC48</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel Injection</intervention_name>
    <description>Administered according to label, as one option for Physician's Choice (determined before randomization)</description>
    <arm_group_label>Physician's Choice</arm_group_label>
    <other_name>Taxol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel Injection</intervention_name>
    <description>Administered according to label, as one option for Physician's Choice (determined before randomization)</description>
    <arm_group_label>Physician's Choice</arm_group_label>
    <other_name>Taxotere</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinorelbine Tartrate Injection</intervention_name>
    <description>Administered according to label, as one option for Physician's Choice (determined before randomization)</description>
    <arm_group_label>Physician's Choice</arm_group_label>
    <other_name>Navelbine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine Tablets</intervention_name>
    <description>Administered according to label, as one option for Physician's Choice (determined before randomization)</description>
    <arm_group_label>Physician's Choice</arm_group_label>
    <other_name>Xeloda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Voluntarily agree to participate in the study and sign the informed consent;&#xD;
&#xD;
          -  Subjects aged 18-70 years (including 18 years and 70 years) and not reaching the 71st&#xD;
             birthday were all considered to be ≤70 years old;&#xD;
&#xD;
          -  Expected survival ≥12 weeks;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group(ECOG) physical condition 0 or 1;&#xD;
&#xD;
          -  For female subjects of child-bearing age women agreed to study during treatment and&#xD;
             experimental subjects within 6 months after the end of the treatment period using an&#xD;
             approved by the medical contraception (e.g. intrauterine device, the pill or condoms),&#xD;
             before the study drug delivery within 7 days of pregnancy blood test must be negative&#xD;
             (sterilization surgery or age 60 or more subjects can choose no pregnancy blood test),&#xD;
             and must be an lactation. For male subjects: should be sterilized surgically, or agree&#xD;
             to use a medically approved contraceptive method during the study period and for 6&#xD;
             months after the end of the treatment period. Control subjects after the end of the&#xD;
             treatment period according to the choice of control drugs to determine the length of&#xD;
             contraception.&#xD;
&#xD;
          -  Able to understand the study requirements and be willing and able to follow the study&#xD;
             and follow-up procedures.&#xD;
&#xD;
          -  Bone marrow function:&#xD;
&#xD;
        hemoglobin ≥9g/dL; absolute neutrophil count ≥1.5×109/L; white blood cell count ≥3.0×109/L&#xD;
        platelet ≥100 ×109/L;&#xD;
&#xD;
          -  Liver function (according to the normal value of the clinical trial center) :&#xD;
&#xD;
        serum total bilirubin ≤1.5 times the upper limit of normal value (ULN); alanine&#xD;
        aminotransferase (ALT), aspartate aminotransferase(AST) and Alkaline phosphatase（ALP） were&#xD;
        ≤2.5 × ULN in the absence of liver metastasis, and ALT, AST and Alkaline phosphatase(ALP)&#xD;
        were ≤5 × ULN in the presence of liver metastasis&#xD;
&#xD;
          -  Renal function (according to the normal value of the clinical trial center) :&#xD;
&#xD;
        serum creatinine ≤1.5×ULN, or calculated by Cockcroft-Gault formula, the creatinine&#xD;
        clearance rate (CrCl) ≥60 mL/min;&#xD;
&#xD;
          -  Cardiac function:&#xD;
&#xD;
        American New York college of cardiology (NYHA) grade &lt; 3; left ventricular ejection&#xD;
        fraction ≥50%;&#xD;
&#xD;
          -  Breast cancer subjects diagnosed by histology and / or cytology are currently at a&#xD;
             locally advanced or metastatic stage and cannot be radically removed;&#xD;
&#xD;
          -  The low expression of HER2 confirmed by the IHC and FISH results of the central&#xD;
             laboratory (defined as: IHC 2+ and no amplification of FISH); the subject can provide&#xD;
             a specimen of the primary or metastatic tumor site (paraffin wax) for HER2 detection&#xD;
             Block, paraffin-embedded section or fresh tissue section can be used);&#xD;
&#xD;
          -  Previous use of anthracycline drugs;&#xD;
&#xD;
          -  Received 1 or 2 systemic chemotherapy treatments after relapse / metastasis. Subjects&#xD;
             who relapsed during adjuvant chemotherapy or within 12 months after the end of&#xD;
             adjuvant chemotherapy were considered to have failed first-line chemotherapy after&#xD;
             relapse / metastasis.&#xD;
&#xD;
          -  Hormone receptors are negative or positive. Hormone receptor-positive subjects need to&#xD;
             progress after receiving endocrine therapy after relapse / metastasis or relapse after&#xD;
             less than 2 years. Patients who are not suitable for endocrine therapy can be included&#xD;
             in this study after undergoing chemotherapy treatment (first-line or second-line);&#xD;
&#xD;
          -  The imaging evidence confirmed by the investigator that the tumor disease progressed&#xD;
             during or after the most recent treatment is required;&#xD;
&#xD;
          -  There has been no diagnosis of HER2 positive (HER2 IHC 3+ or FISH amplification)&#xD;
&#xD;
          -  Have not used drugs targeting HER2 (including antibodies, small molecule Tyrosine&#xD;
             kinase inhibitor（TKIs） and antibody drug conjugates).&#xD;
&#xD;
          -  According to the RECIST 1.1 standard, there is at least one measurable lesion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received chemotherapy within 4 weeks before the start of study administration&#xD;
             (treatment with nitrosourea and mitomycin C within 6 weeks, oral fluorouracil within 2&#xD;
             weeks), radiotherapy (palliative for bone metastases Local radiotherapy is within 2&#xD;
             weeks before study administration), immunotherapy; received endocrine therapy for&#xD;
             breast cancer within 2 weeks before study administration;&#xD;
&#xD;
          -  The research drug was used within 4 weeks before the start of study administration;&#xD;
&#xD;
          -  Have undergone major surgery within 4 weeks before the start of study administration;&#xD;
&#xD;
          -  Have received a live vaccine within 4 weeks before the start of study administration&#xD;
             or plan to receive any vaccine during the study period;&#xD;
&#xD;
          -  Serious cardiovascular and cerebrovascular events occurred within 12 months, including&#xD;
             but not limited to unstable angina, myocardial infarction, cerebral hemorrhage, and&#xD;
             cerebral infarction (except for asymptomatic and untreated lacunar infarction)；&#xD;
&#xD;
          -  Those who are suffering from heart disease are not suitable for enrollment, including&#xD;
             but not limited to arrhythmia and heart failure requiring medical treatment or&#xD;
             accompanied by symptoms;&#xD;
&#xD;
          -  There are other lung diseases requiring treatment or serious, including but not&#xD;
             limited to active pulmonary tuberculosis, interstitial lung disease, etc ;&#xD;
&#xD;
          -  Suffering from active infection requiring systemic treatment;&#xD;
&#xD;
          -  Have active autoimmune diseases (such as the use of corticosteroids or&#xD;
             immunosuppressive drugs, etc.) that require systemic treatment within the past 2&#xD;
             years, allowing related alternative treatments (such as thyroxine, insulin, or the&#xD;
             physiology of adrenal or pituitary insufficiency Corticosteroid replacement therapy);&#xD;
&#xD;
          -  The toxicity of the previous anti-tumor therapy has not been restored to the 0 to 1&#xD;
             level defined by CTCAE version 5.0, of which the neurotoxicity has not been restored&#xD;
             to 0; except for hair loss, pigmentation or other researches that do not increase the&#xD;
             risk of medication Happening;&#xD;
&#xD;
          -  Have a clear past or current history of neurological or mental disorders, including&#xD;
             epilepsy or dementia;&#xD;
&#xD;
          -  According to the investigator's judgment, there are concomitant diseases that&#xD;
             seriously endanger the safety of the subject or affect the completion of the clinical&#xD;
             study；&#xD;
&#xD;
          -  Positive HIV test results; patients with active hepatitis B or C (HBsAg positive and&#xD;
             hepatitis B virus（HBV） DNA titers above the upper limit of normal; Hepatitis C Virus&#xD;
             Antibody(HCVAb) positive hepatitis C virus （HCV） RNA titers above the upper limit of&#xD;
             normal)；&#xD;
&#xD;
          -  There is a third interstitial fluid that cannot be controlled by drainage or other&#xD;
             methods (including a large amount of pleural effusion or ascites);&#xD;
&#xD;
          -  Known hypersensitivity or delayed allergic reaction to certain components of RC48-ADC&#xD;
             or similar drugs;&#xD;
&#xD;
          -  Subjects who are not suitable for using any of the alternative control drugs;&#xD;
&#xD;
          -  The presence of brain metastases and / or cancerous meningitis;&#xD;
&#xD;
          -  Have other malignant tumors within 5 years before signing the informed consent form&#xD;
             (except for non-melanoma skin cancer, cervical carcinoma in situ or other tumors that&#xD;
             have been effectively treated, except malignant tumors that are considered cured);&#xD;
&#xD;
          -  Subjects who are estimated to be inadequate for patients to participate in this&#xD;
             clinical study or other factors that the investigator believes are inappropriate to&#xD;
             participate in this study;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Binghe Xu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oncology Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tao Sun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liaoning Tumor Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wei Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jilin University First Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yuee Teng</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of China Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shu Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaojia Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Min Yan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henan Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jifeng Feng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jiangsu Cancer Institute &amp; Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ying Cheng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jilin Provincial Tumor Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ying Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen Memorial Hospital,Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ying Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University Cancer Prevention and Control Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ning Liao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Haibo Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qingdao University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Quchang Ouyang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hunan Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yueyin Pan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anhui Provincial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yingying Du</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Anhui Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Changlu Hu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anhui Provincial Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhongsheng Tong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jin Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lihua Song</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong Cancer Hospital and Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiuwen Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qilu Hospital of Shandong University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yu Jiang</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yunjiang Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Fourth Hospital of Hebei Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jing Cheng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan Union Hospital, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huihua Xiong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xinhong Wu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hubei Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peng Shen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Weimin Xie</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Hospital Affiliated to Guangxi Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xin Zhou</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chongqing University Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Li Ran</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Hospital of Guizhou Province</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yu Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanxi Province Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jinnan Gao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bethune Hospital of Shanxi Province</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jingfen Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linyi Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liangming Zhang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yantai Yuhuangding Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xianhe Xie</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Fujian Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ru Zeng</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Xiamen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Airong Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weihai Municipal Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhengqiu Zhu</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Affiliated Hospital of Xuzhou Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sanyuan Sun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xuzhou Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qingshan Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital of Chengde Medical College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aimin Zang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital of Hebei University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liuzhong Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Xinxiang Medical College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Meili Sun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jinan Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liang Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zibo Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guohua Yu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weifang People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xujuan Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neijiang Second People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Binghe Xu, M.D.</last_name>
    <phone>010-87788826</phone>
    <email>bhxu@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Oncology Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Binghe Xu</last_name>
      <phone>010-87788826</phone>
      <email>bhxu@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>April 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>November 24, 2021</last_update_submitted>
  <last_update_submitted_qc>November 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2021</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Vinorelbine</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04400695
org study id: RC48-C012
nct id: NCT04400695
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will compare RC48-ADC to physician choice standard treatment. Participants must
      have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one
      or two systemic chemotherapy regimens following recurrence/metastasis.
This study is a multi-center, randomized, open, parallel control to evaluate the
      effectiveness and safety of Phase III clinical trials of the efficacy and safety of
      recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate
      for the treatment of locally advanced or metastatic breast cancer the study.The low
      expression of HER2 is defined as: the immunohistochemistry (IHC) confirmed by the central
      laboratory detects the expression of HER2 protein as IHC 2+ and the fluorescence in situ
      hybridization (FISH) detection has no amplification.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (PFS), evaluated by an independent efficacy evaluation committee
time frame: within approximately 3 years
description: Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
measure: Progression-free survival (PFS), evaluated by the investigator
time frame: within approximately 3 years
description: Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
measure: Objective remission rate (ORR)
time frame: within approximately 3 years
description: The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).
measure: Duration of relief (DOR)
time frame: within approximately 3 years
description: DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
measure: Disease control rate (DCR)
time frame: within approximately 3 years
description: Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
measure: Tumor progression time (TTP)
time frame: within approximately 3 years
description: Time to disease progression (TTP) refers to the time from the random date to the first disease progression (calculated by the event that occurred first). Disease progression will be evaluated by the investigator according to the RECIST 1.1 standard (investigator and Independent Review Committee(IRC) evaluation).
measure: Overall survival (OS)
time frame: within approximately 3 years
description: Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
arm group label: RC48-ADC
arm group type: Experimental
description: RC48-ADC common name：Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection Dosage form：Lyophilized powder injection specification：60 mg / piece Medication plan：Every 2 weeks Expiration date：18 months HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis.
arm group label: Physician's Choice
arm group type: Active Comparator
description: Physician's Choice:
HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis.
Physician's choice from the following options:
Paclitaxel Injection Docetaxel Injection Vinorelbine Tartrate Injection Capecitabine Tablets
intervention type: Drug
intervention name: RC48-ADC
description: RC48-ADC 2.0mg / kg, intravenous drip, once every 2 weeks
arm group label: RC48-ADC
other name: RC48
intervention type: Drug
intervention name: Paclitaxel Injection
description: Administered according to label, as one option for Physician's Choice (determined before randomization)
arm group label: Physician's Choice
other name: Taxol
intervention type: Drug
intervention name: Docetaxel Injection
description: Administered according to label, as one option for Physician's Choice (determined before randomization)
arm group label: Physician's Choice
other name: Taxotere
intervention type: Drug
intervention name: Vinorelbine Tartrate Injection
description: Administered according to label, as one option for Physician's Choice (determined before randomization)
arm group label: Physician's Choice
other name: Navelbine
intervention type: Drug
intervention name: Capecitabine Tablets
description: Administered according to label, as one option for Physician's Choice (determined before randomization)
arm group label: Physician's Choice
other name: Xeloda
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Binghe Xu
role: Principal Investigator
affiliation: Oncology Hospital, Chinese Academy of Medical Sciences
last name: Tao Sun
role: Principal Investigator
affiliation: Liaoning Tumor Hospital & Institute
last name: Wei Li
role: Principal Investigator
affiliation: Jilin University First Hospital
last name: Yuee Teng
role: Principal Investigator
affiliation: First Affiliated Hospital of China Medical University
last name: Shu Wang
role: Principal Investigator
affiliation: Peking University People's Hospital
last name: Xiaojia Wang
role: Principal Investigator
affiliation: Zhejiang Cancer Hospital
last name: Min Yan
role: Principal Investigator
affiliation: Henan Cancer Hospital
last name: Jifeng Feng
role: Principal Investigator
affiliation: Jiangsu Cancer Institute & Hospital
last name: Ying Cheng
role: Principal Investigator
affiliation: Jilin Provincial Tumor Hospital
last name: Ying Wang
role: Principal Investigator
affiliation: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
last name: Ying Wang
role: Principal Investigator
affiliation: Sun Yat-sen University Cancer Prevention and Control Center
last name: Ning Liao
role: Principal Investigator
affiliation: Guangdong Provincial People's Hospital
last name: Haibo Wang
role: Principal Investigator
affiliation: Qingdao University Hospital
last name: Quchang Ouyang
role: Principal Investigator
affiliation: Hunan Cancer Hospital
last name: Yueyin Pan
role: Principal Investigator
affiliation: Anhui Provincial Hospital
last name: Yingying Du
role: Principal Investigator
affiliation: The First Affiliated Hospital of Anhui Medical University
last name: Changlu Hu
role: Principal Investigator
affiliation: Anhui Provincial Cancer Hospital
last name: Zhongsheng Tong
role: Principal Investigator
affiliation: Tianjin Cancer Hospital
last name: Jin Yang
role: Principal Investigator
affiliation: The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
last name: Lihua Song
role: Principal Investigator
affiliation: Shandong Cancer Hospital and Institute
last name: Xiuwen Wang
role: Principal Investigator
affiliation: Qilu Hospital of Shandong University
last name: Yu Jiang
role: Principal Investigator
affiliation: West China Hospital
last name: Yunjiang Liu
role: Principal Investigator
affiliation: The Fourth Hospital of Hebei Medical University
last name: Jing Cheng
role: Principal Investigator
affiliation: Wuhan Union Hospital, China
last name: Huihua Xiong
role: Principal Investigator
affiliation: Tongji Hospital
last name: Xinhong Wu
role: Principal Investigator
affiliation: Hubei Cancer Hospital
last name: Peng Shen
role: Principal Investigator
affiliation: Zhejiang University
last name: Weimin Xie
role: Principal Investigator
affiliation: Cancer Hospital Affiliated to Guangxi Medical University
last name: Xin Zhou
role: Principal Investigator
affiliation: Chongqing University Cancer Hospital
last name: Li Ran
role: Principal Investigator
affiliation: Cancer Hospital of Guizhou Province
last name: Yu Wang
role: Principal Investigator
affiliation: Shanxi Province Cancer Hospital
last name: Jinnan Gao
role: Principal Investigator
affiliation: Bethune Hospital of Shanxi Province
last name: Jingfen Wang
role: Principal Investigator
affiliation: Linyi Cancer Hospital
last name: Liangming Zhang
role: Principal Investigator
affiliation: Yantai Yuhuangding Hospital
last name: Xianhe Xie
role: Principal Investigator
affiliation: First Affiliated Hospital of Fujian Medical University
last name: Ru Zeng
role: Principal Investigator
affiliation: The First Affiliated Hospital of Xiamen University
last name: Airong Wang
role: Principal Investigator
affiliation: Weihai Municipal Hospital
last name: Zhengqiu Zhu
role: Principal Investigator
affiliation: The Affiliated Hospital of Xuzhou Medical University
last name: Sanyuan Sun
role: Principal Investigator
affiliation: Xuzhou Central Hospital
last name: Qingshan Li
role: Principal Investigator
affiliation: Affiliated Hospital of Chengde Medical College
last name: Aimin Zang
role: Principal Investigator
affiliation: Affiliated Hospital of Hebei University
last name: Liuzhong Yang
role: Principal Investigator
affiliation: The First Affiliated Hospital of Xinxiang Medical College
last name: Meili Sun
role: Principal Investigator
affiliation: Jinan Central Hospital
last name: Liang Li
role: Principal Investigator
affiliation: Zibo Central Hospital
last name: Guohua Yu
role: Principal Investigator
affiliation: Weifang People's Hospital
last name: Xujuan Wang
role: Principal Investigator
affiliation: Neijiang Second People's Hospital
last name: Binghe Xu, M.D.
phone: 010-87788826
email: bhxu@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Paclitaxel
mesh term: Vinorelbine
mesh term: Docetaxel
mesh term: Capecitabine
sharing ipd: No