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/NCT06015100</url>
    </required_header>
    <id_info>
      <org_study_id>CORP-239-Ｎ3</org_study_id>
      <nct_id>NCT06015100</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis</brief_title>
    <official_title>Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yan Xue</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xi'an International Medical Center Hospital</source>
    <oversight_info>
      <has_dmc>No</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 intends to include HER2-positive metastatic breast cancer patients (with or&#xD;
        without brain metastasis) who have become resistant to previous treatment with trastuzumab.&#xD;
        It will use pertuzumab in combination with pyrotinib and capecitabine to observe efficacy and&#xD;
        safety. The choice of capecitabine as the chemotherapy drug is mainly based on the following&#xD;
        reasons: ① it has been less commonly used as neoadjuvant treatment, making it less prone to&#xD;
        cross-resistance; ② its oral formulation is convenient for administration, making it more&#xD;
        acceptable to patients; ③ previous studies have shown good efficacy when combined with&#xD;
        pyrotinib; ④ previous research in breast cancer patients with brain metastasis has also&#xD;
        demonstrated certain effectiveness. It is hoped that through this study, preliminary evidence&#xD;
        can be provided for the dual-target treatment of original Chinese drugs, as well as the&#xD;
        treatment of HER2+ MBC after resistance to trastuzumab, and the addition of new data for&#xD;
        patients with brain metastasis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Research Title A single-center, open-label, single-arm clinical study on the efficacy and&#xD;
        safety of pertuzumab in combination with pyrotinib and capecitabine in the treatment of&#xD;
        HER2-positive metastatic breast cancer patients who have developed resistance to previous&#xD;
        trastuzumab treatment (with or without brain metastasis).&#xD;
  &#xD;
        Study Drugs - Injectable pertuzumab: 50mg/vial - Pyrotinib: 80mg/tablet&#xD;
  &#xD;
        Research Objective To evaluate the effectiveness and safety of pertuzumab in combination with&#xD;
        pyrotinib and capecitabine in the treatment of HER2-positive metastatic breast cancer&#xD;
        patients who have developed resistance to previous trastuzumab treatment (with or without&#xD;
        brain metastasis). This study aims to provide preliminary evidence for the dual-target&#xD;
        treatment of original Chinese drugs, and to add new data to the treatment model for&#xD;
        trastuzumab-resistant HER2+ MBC and patients with brain metastasis.&#xD;
  &#xD;
        Study Design A single-center, open-label, single-arm clinical study with a planned enrollment&#xD;
        of 40 patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">February 20, 2021</start_date>
    <completion_date type="Anticipated">August 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </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 100 months</time_frame>
      <description>It is an indicator of the long-term efficacy of the drug</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate</measure>
      <time_frame>4 weeks</time_frame>
      <description>The proportion of patients with the best response of complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate</measure>
      <time_frame>4 weeks</time_frame>
      <description>The proportion of patients with tumor shrinkage or stability maintained for a certain period, including cases of CR, PR, and stable disease (SD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>the time from randomization to death from any cause, assessed up to 100 months.</time_frame>
      <description>It is an indicator of the long-term efficacy of the drug</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Label 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Inetetamab plus pyrotiniband and capecitabine</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Inetetamab plus pyrotiniband and capecitabine</intervention_name>
      <description>Inetetamab plus pyrotiniband and capecitabine</description>
      <arm_group_label>Label 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who can voluntarily sign an informed consent form;&#xD;
  &#xD;
            -  Females aged ≥18 years at the time of signing the informed consent form;&#xD;
  &#xD;
            -  ECOG PS performance status score between 0 and 2;&#xD;
  &#xD;
            -  Patients histologically diagnosed with HER2-positive metastatic breast cancer, with or&#xD;
               without brain metastasis, and with locally recurrent disease that cannot undergo&#xD;
               curative surgery or radiation therapy;&#xD;
  &#xD;
            -  Patients who experience relapse or metastasis within 1 year during or after&#xD;
               (neo)adjuvant pertuzumab-based targeted therapy, or disease progression during&#xD;
               first-line pertuzumab-based targeted therapy in advanced stages;&#xD;
  &#xD;
            -  Patients who have received ≤1 regimen of previous pertuzumab-based targeted therapy&#xD;
               for recurrent or metastatic disease;&#xD;
  &#xD;
            -  Brain metastasis patients must meet the following criteria: stable previous brain&#xD;
               metastasis treatment, untreated brain metastasis with no immediate need for local&#xD;
               treatment, or progressive previous brain metastasis without immediate need for local&#xD;
               treatment;&#xD;
  &#xD;
            -  Left ventricular ejection fraction (LVEF) ≥50%;&#xD;
  &#xD;
            -  Blood routine examination meets the following conditions: ① absolute neutrophil count&#xD;
               (ANC) ≥1.5×109/L, ② platelet count ≥100×109/L, ③ hemoglobin ≥90g/L, ④ white blood cell&#xD;
               count ≥3.0×109/L;&#xD;
  &#xD;
            -  Liver function meets the following conditions: ① serum total bilirubin ≤1.5×ULN, or&#xD;
               ≤3×ULN if liver metastasis is present, ② aspartate aminotransferase (AST) or alanine&#xD;
               aminotransferase (ALT) ≤3×ULN, or ≤5×ULN if liver metastasis is present;&#xD;
  &#xD;
            -  Renal function meets the following conditions: serum creatinine ≤1.5×ULN or creatinine&#xD;
               clearance ≥50 mL/min (creatinine clearance calculated according to the Cockcroft-Gault&#xD;
               formula);&#xD;
  &#xD;
            -  Female patients who meet the following conditions can participate in this study: ① not&#xD;
               fertile; ② fertility potential, with a negative pregnancy test result within 7 days&#xD;
               before the first administration of the study drug, not breastfeeding, and consistently&#xD;
               using highly effective contraceptive measures before study enrollment, throughout the&#xD;
               study period, and within 6 months after the last administration of the study drug.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who have previously received Inetetamab and/or pyrotinib treatment;&#xD;
  &#xD;
            -  Those who have received capecitabine treatment within the past 2 weeks before&#xD;
               randomization;&#xD;
  &#xD;
            -  Patients with noticeable symptoms who require immediate local treatment for brain&#xD;
               metastasis;&#xD;
  &#xD;
            -  Exclusion criteria include having had or currently having any other malignant tumors&#xD;
               within the past 5 years, except for cured cervical intraepithelial neoplasia,&#xD;
               non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis&#xD;
               (in situ carcinoma), and T1 (tumor invasion of the basement membrane)];&#xD;
  &#xD;
            -  Exclusion criteria include having undergone major surgical procedures (including&#xD;
               thoracotomy biopsy) within the past 4 weeks before randomization, suffering from major&#xD;
               trauma (such as bone fracture), having unhealed wounds or fractures at the time of&#xD;
               screening, or anticipating the need for major surgery during the study treatment&#xD;
               period;&#xD;
  &#xD;
            -  Exclusion criteria include having a history of myocardial infarction within the past 6&#xD;
               months; New York Heart Association (NYHA) class ≥ II congestive heart failure history,&#xD;
               severe arrhythmia uncontrolled by medication (excluding atrial fibrillation,&#xD;
               paroxysmal supraventricular tachycardia); known decrease in left ventricular ejection&#xD;
               fraction (LVEF) to below 50% during or after previous trastuzumab treatment;&#xD;
  &#xD;
            -  Known allergy to the drugs and excipients involved in this trial;&#xD;
  &#xD;
            -  Known history of hypersensitivity reactions to any investigational drug;&#xD;
  &#xD;
            -  Subjects deemed unfit for participation by other researchers.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yan Xue</last_name>
      <role>Principal Investigator</role>
      <affiliation>Xi'an International Medical Center Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Xi'an International Medical Center Hospital</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710100</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Xi'an International Medical Center Hospital</investigator_affiliation>
      <investigator_full_name>Yan Xue</investigator_full_name>
      <investigator_title>Director of tumor hospital</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Brain Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
  
  
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/NCT06015100
  org study id: CORP-239-Ｎ3
  nct id: NCT06015100
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study intends to include HER2-positive metastatic breast cancer patients (with or
        without brain metastasis) who have become resistant to previous treatment with trastuzumab.
        It will use pertuzumab in combination with pyrotinib and capecitabine to observe efficacy and
        safety. The choice of capecitabine as the chemotherapy drug is mainly based on the following
        reasons: ① it has been less commonly used as neoadjuvant treatment, making it less prone to
        cross-resistance; ② its oral formulation is convenient for administration, making it more
        acceptable to patients; ③ previous studies have shown good efficacy when combined with
        pyrotinib; ④ previous research in breast cancer patients with brain metastasis has also
        demonstrated certain effectiveness. It is hoped that through this study, preliminary evidence
        can be provided for the dual-target treatment of original Chinese drugs, as well as the
        treatment of HER2+ MBC after resistance to trastuzumab, and the addition of new data for
        patients with brain metastasis.
  Research Title A single-center, open-label, single-arm clinical study on the efficacy and
        safety of pertuzumab in combination with pyrotinib and capecitabine in the treatment of
        HER2-positive metastatic breast cancer patients who have developed resistance to previous
        trastuzumab treatment (with or without brain metastasis).
  
        Study Drugs - Injectable pertuzumab: 50mg/vial - Pyrotinib: 80mg/tablet
  
        Research Objective To evaluate the effectiveness and safety of pertuzumab in combination with
        pyrotinib and capecitabine in the treatment of HER2-positive metastatic breast cancer
        patients who have developed resistance to previous trastuzumab treatment (with or without
        brain metastasis). This study aims to provide preliminary evidence for the dual-target
        treatment of original Chinese drugs, and to add new data to the treatment model for
        trastuzumab-resistant HER2+ MBC and patients with brain metastasis.
  
        Study Design A single-center, open-label, single-arm clinical study with a planned enrollment
        of 40 patients.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  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 100 months
  description: It is an indicator of the long-term efficacy of the drug
  measure: Objective Response Rate
  time frame: 4 weeks
  description: The proportion of patients with the best response of complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST).
  measure: Disease Control Rate
  time frame: 4 weeks
  description: The proportion of patients with tumor shrinkage or stability maintained for a certain period, including cases of CR, PR, and stable disease (SD).
  measure: Overall survival
  time frame: the time from randomization to death from any cause, assessed up to 100 months.
  description: It is an indicator of the long-term efficacy of the drug
  arm group label: Label 1
  arm group type: Experimental
  description: Inetetamab plus pyrotiniband and capecitabine
  intervention type: Drug
  intervention name: Inetetamab plus pyrotiniband and capecitabine
  description: Inetetamab plus pyrotiniband and capecitabine
  arm group label: Label 1
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yan Xue
  role: Principal Investigator
  affiliation: Xi'an International Medical Center Hospital
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Xi'an International Medical Center Hospital
  investigator full name: Yan Xue
  investigator title: Director of tumor hospital
  mesh term: Breast Neoplasms
  mesh term: Brain Neoplasms
  mesh term: Capecitabine
  sharing ipd: No