xml: <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/NCT05980208</url>
    </required_header>
    <id_info>
      <org_study_id>KY-2023071101</org_study_id>
      <nct_id>NCT05980208</nct_id>
    </id_info>
    <brief_title>A Real-world Study of Inetetamab for First-line Treatment of MBC</brief_title>
    <official_title>A Real-world Study of Inetetamab for First-line Treatment of HER2-positive Inoperable Locally Advanced or Relapsed Metastatic Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hunan Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hunan Medical University General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hunan Cancer Hospital</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 is a prospective, multicenter, real-world study aimed at evaluating the efficacy and&#xD;
        safety of inetetamab+chemotherapy or inetetamab+pyrotinib+chemotherapy or&#xD;
        inetetamab+pertuzumab+chemotherapy in the treatment of HER2 positive inoperable locally&#xD;
        advanced or recurrent metastatic breast cancer. The research results will provide new&#xD;
        targeted treatment strategies for HER2 positive breast cancer patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Progression-Free Survival</measure>
      <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months</time_frame>
      <description>The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 60 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate</measure>
      <time_frame>From date of randomization until the date at the end of the second treatment cycle (42 days)</time_frame>
      <description>The total rate of CR+PR after the completion of two cycles of treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>The time from randomization to death from any cause, whichever came first, assessed up to 60 months</time_frame>
      <description>The time from randomization to death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Events</measure>
      <time_frame>The time from randomization to reach the endpoint, assessed up to 60 months</time_frame>
      <description>All adverse events [including adverse events (AE / SAE) and ADR (adverse drug reactions)] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Real-world Study</condition>
    <arm_group>
      <arm_group_label>Inetetamab</arm_group_label>
      <description>Inetetamab-based treatment for first-line treatment of HER2-positive MBC</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Inetetamab</intervention_name>
      <description>Inetetamab-based treatment for first-line treatment of HER2-positive MBC</description>
      <arm_group_label>Inetetamab</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          First-line treatment of HER2 positive inoperable local advanced or recurrent metastatic&#xD;
          breast cancer patients.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged ≥18 years and ≤75 years;Patients aged ≥18 years and ≤75 years;&#xD;
  &#xD;
            -  Her2-positive invasive breast cancer confirmed by pathological examination met the&#xD;
               following conditions:&#xD;
  &#xD;
          Positive HER2 expression: Immunohistochemical staining (IHC) showed positive HER2 3+ and/or&#xD;
          fluorescence in situ hybridization (FISH); Tumor staging: inoperable locally advanced or&#xD;
          recurrent metastatic breast cancer; Patients with local recurrence must be confirmed by the&#xD;
          investigator to be unable to undergo radical surgical excision.&#xD;
  &#xD;
            -  At least one measurable lesion was present according to RECIST1.1 criteria;&#xD;
  &#xD;
            -  The ECOG score is 0 to 1;&#xD;
  &#xD;
            -  No systematic antitumor therapy (except first-line endocrine therapy) has been&#xD;
               received at the locally advanced stage (clinically inoperable) or at the stage of&#xD;
               recurrence and metastasis;&#xD;
  &#xD;
            -  The functional level of major organs must meet the following requirements (no blood&#xD;
               transfusion within 2 weeks prior to screening, no use of leukocyte enhancing and&#xD;
               platelet enhancing drugs) :&#xD;
  &#xD;
                 1. Blood routine: neutrophils (ANC) ≥1.5×109/L; Platelet count (PLT) ≥90×109/L;&#xD;
                    Hemoglobin (Hb) ≥90 g/L;&#xD;
  &#xD;
                 2. Blood biochemistry: total bilirubin (TBIL) ≤ upper limit of normal value (ULN),&#xD;
                    known patients with Gilbert syndrome, TBIL≤2×ULN; Alanine aminotransferase (ALT)&#xD;
                    and aspartate aminotransferase (AST) ≤1.5×ULN, patients with liver metastasis&#xD;
                    required ALT and AST≤5×ULN; Alkaline phosphatase ≤2.5×ULN; Urea/urea nitrogen&#xD;
                    (BUN) and creatinine (Cr) ≤1.5×ULN;&#xD;
  &#xD;
                 3. Cardiac ultrasound: left ventricular ejection fraction (LVEF) ≥50%;&#xD;
  &#xD;
                 4. 12-lead electrocardiogram: Fridericia corrected QT interval (QTcF) &lt;470 msec;&#xD;
  &#xD;
            -  Expected survival ≥3 months;&#xD;
  &#xD;
            -  Participate in this study voluntarily, sign informed consent, have good compliance and&#xD;
               be willing to cooperate with follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known allergic history of drug components of the program;&#xD;
  &#xD;
            -  Patients judged unsuitable for systematic chemotherapy by researchers;&#xD;
  &#xD;
            -  Use of endocrine therapy drugs within 14 days before baseline;&#xD;
  &#xD;
            -  Patients with only bone or skin as target lesions;&#xD;
  &#xD;
            -  Other malignancies, excluding cured cervical carcinoma in situ, skin basal cell&#xD;
               carcinoma or squamous cell carcinoma, within the previous 5 years;&#xD;
  &#xD;
            -  Peripheral neuropathy ≥ grade 3 according to CTCAE 5.0 criteria;&#xD;
  &#xD;
            -  Had received major surgical procedures or significant trauma within 4 weeks prior to&#xD;
               randomization, or was expected to receive major surgical treatment;&#xD;
  &#xD;
            -  Serious heart disease or discomfort, including but not limited to:&#xD;
  &#xD;
          heart failure or contraction dysfunction (LVEF &lt;50%) past medical history high risk or the&#xD;
          need for treatment of angina or arrhythmia (such as second degree atrioventricular block&#xD;
          type 2 or 3 degree atrioventricular block, ventricular tachycardia) clinical significance&#xD;
          of heart valve disease ECG showed wall permeability myocardial infarction poorly controlled&#xD;
          hypertension, systolic blood pressure&gt;150 mmHg and/or diastolic blood pressure&gt;100 mmHg&#xD;
  &#xD;
            -  Dysphagia, chronic diarrhea, intestinal obstruction and other factors affecting drug&#xD;
               delivery and absorption;&#xD;
  &#xD;
            -  A history of immunodeficiency, including HIV infection, or other acquired, congenital&#xD;
               immunodeficiency diseases, or a history of organ transplantation;&#xD;
  &#xD;
            -  Participated in other drug clinical studies within 4 weeks prior to screening;&#xD;
  &#xD;
            -  There is a third interstitial effusion (such as pleural fluid and ascites) that cannot&#xD;
               be controlled by drainage or other methods;&#xD;
  &#xD;
            -  Pregnant or lactating women, women of childbearing age who are unable to take&#xD;
               effective contraceptive measures throughout the trial period;&#xD;
  &#xD;
            -  Have a serious concomitant disease or other co-medical condition that interferes with&#xD;
               planned treatment or any other condition that is not suitable for participation in the&#xD;
               study, such as active hepatitis B, lung infection requiring treatment, etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Quchang Ouyang, Prof. Dr.</last_name>
      <phone>+86 13973135318</phone>
      <email>ouyangquchang@hnca.org.cn</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>breast cancer</keyword>
    <keyword>real-world study</keyword>
    <keyword>HER2-postive</keyword>
    <keyword>inetetamab</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980208
  org study id: KY-2023071101
  nct id: NCT05980208
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, multicenter, real-world study aimed at evaluating the efficacy and
        safety of inetetamab+chemotherapy or inetetamab+pyrotinib+chemotherapy or
        inetetamab+pertuzumab+chemotherapy in the treatment of HER2 positive inoperable locally
        advanced or recurrent metastatic breast cancer. The research results will provide new
        targeted treatment strategies for HER2 positive breast cancer patients.
  observational model: Cohort
  time perspective: Prospective
  measure: Progression-Free Survival
  time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
  description: The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 60 months
  measure: Objective Response Rate
  time frame: From date of randomization until the date at the end of the second treatment cycle (42 days)
  description: The total rate of CR+PR after the completion of two cycles of treatment.
  measure: Overall survival
  time frame: The time from randomization to death from any cause, whichever came first, assessed up to 60 months
  description: The time from randomization to death from any cause
  measure: Adverse Events
  time frame: The time from randomization to reach the endpoint, assessed up to 60 months
  description: All adverse events [including adverse events (AE / SAE) and ADR (adverse drug reactions)] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.
  arm group label: Inetetamab
  description: Inetetamab-based treatment for first-line treatment of HER2-positive MBC
  intervention type: Drug
  intervention name: Inetetamab
  description: Inetetamab-based treatment for first-line treatment of HER2-positive MBC
  arm group label: Inetetamab
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  last name: Quchang Ouyang, Prof. Dr.
  phone: +86 13973135318
  email: ouyangquchang@hnca.org.cn
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: Undecided