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/NCT06001086</url>
    </required_header>
    <id_info>
      <org_study_id>20230722RC48</org_study_id>
      <nct_id>NCT06001086</nct_id>
    </id_info>
    <brief_title>A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer</brief_title>
    <official_title>A Multicenter, Open Phase II Clinical Study to Evaluate the Efficacy and Safety of Disitamb Vedotin Combined With Pyrotinib in Previously Untreated Histologically Proven HER2 Positive Early Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital with Nanjing Medical University</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>
        Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive&#xD;
        early breast cancer&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main goal of this clinical trial is to evaluate the efficacy of Disitamb Vedotin combined&#xD;
        with pyrotinib in previously untreated histologically proven HER2 positive early breast&#xD;
        cancer and evaluate the PCR DFS,OS and safety of the subjects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 21, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</primary_completion_date>
    <phase>Phase 2</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>pathologic complete response（pCR）</measure>
      <time_frame>1 year</time_frame>
      <description>The pCR rate is defined as the proportion of subjects who, after completion of neoadjuvant therapy, showed no evidence of residual invasive lesions in H&amp;E staining in completely excised breast specimens and all sampled local lymph nodes (ypT0/TisypN0) through central evaluation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Disease free survival （DFS)</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Breast-conserving surgery（BCS）</measure>
      <time_frame>Intraoperative</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Number of Participants Who Experienced Adverse Events (AE)</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Residual Cancer Burden（RCB）</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life（HRQoL）questionnaire</measure>
      <time_frame>3 years</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Disitamb Vedotin combined with pyrotinib</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Disitamb Vedotin: 2 mg/kg，ivgtt，d1,14/28day/cycle pyrotinib:320mg, oral, every day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Disitamb Vedotin ,pyrotinib</intervention_name>
      <description>Disitamb Vedotin combined with pyrotinib</description>
      <arm_group_label>Disitamb Vedotin combined with pyrotinib</arm_group_label>
      <other_name>Regular Visits</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1.18 to 75 years old (at the time of signing the informed consent form), regardless of&#xD;
          gender.&#xD;
  &#xD;
          2. Subject type and disease characteristics. Histologically confirmed HER2 positive EBC&#xD;
          subjects: (a) evaluated as HER2 positive in local laboratories according to ASCOCAP&#xD;
          guidelines. (b) Single and multifocal tumors (greater than 1 tumor area limited to the same&#xD;
          quadrant as the primary tumor) must be sampled from 1 lesion and laboratory confirmed as&#xD;
          HER2 positive. (c) Multicenter tumors (multiple tumors involving more than one breast&#xD;
          quadrant) must sample one lesion from each affected quadrant and be confirmed as HER2&#xD;
          positive by the central laboratory. (d) According to ASCOCAP guidelines, tumors are either&#xD;
          HR positive or HR negative (ER and PgR negative). (e) Clinical staging at visit (based on&#xD;
          breast X-ray or breast MRI evaluation): Stage II-IIIC determined by the AJCC staging&#xD;
          system, 8th edition. (f) Lymph node involvement is determined by fine needle aspiration or&#xD;
          coarse needle aspiration biopsy (if applicable).&#xD;
  &#xD;
          3. When randomized, ECOG physical fitness status is 0 or 1 point.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous history of invasive breast cancer.&#xD;
  &#xD;
            2. Stage IV breast cancer according to AJCC staging system version 8.&#xD;
  &#xD;
            3. Within 3 years, there is any primary malignant tumor, except for fully resected&#xD;
               non-melanoma skin cancer or cured in situ disease.&#xD;
  &#xD;
            4. DCIS medical history, except for the subjects who only received Mastectomy&#xD;
  &#xD;
            5. According to the judgment of the researchers, there is evidence of any diseases (such&#xD;
               as severe or uncontrolled systemic diseases, including persistent or active&#xD;
               infections, uncontrolled hypertension, kidney transplantation and active bleeding&#xD;
               diseases, and severe chronic gastrointestinal diseases related to diarrhea) that the&#xD;
               researchers consider to be unfavorable for the participants to participate in the&#xD;
               study or may affect adherence to the protocol.&#xD;
  &#xD;
            6. Uncontrolled infection requiring intravenous administration of antibiotics, Antiviral&#xD;
               drug or antifungal drugs.&#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>Wei Li, Ph.D</last_name>
      <phone>025-68307102</phone>
      <email>real.lw@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Jiangsu Provincial People's Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HER2-positive</keyword>
    <keyword>RC48</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>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/NCT06001086
  org study id: 20230722RC48
  nct id: NCT06001086
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive
        early breast cancer
  The main goal of this clinical trial is to evaluate the efficacy of Disitamb Vedotin combined
        with pyrotinib in previously untreated histologically proven HER2 positive early breast
        cancer and evaluate the PCR DFS,OS and safety of the subjects.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: pathologic complete response（pCR）
  time frame: 1 year
  description: The pCR rate is defined as the proportion of subjects who, after completion of neoadjuvant therapy, showed no evidence of residual invasive lesions in H&E staining in completely excised breast specimens and all sampled local lymph nodes (ypT0/TisypN0) through central evaluation
  measure: Disease free survival （DFS)
  time frame: 3 years
  measure: Breast-conserving surgery（BCS）
  time frame: Intraoperative
  measure: The Number of Participants Who Experienced Adverse Events (AE)
  time frame: 1 year
  measure: Residual Cancer Burden（RCB）
  time frame: 3 years
  measure: Health-related quality of life（HRQoL）questionnaire
  time frame: 3 years
  arm group label: Disitamb Vedotin combined with pyrotinib
  arm group type: Experimental
  description: Disitamb Vedotin: 2 mg/kg，ivgtt，d1,14/28day/cycle pyrotinib:320mg, oral, every day.
  intervention type: Drug
  intervention name: Disitamb Vedotin ,pyrotinib
  description: Disitamb Vedotin combined with pyrotinib
  arm group label: Disitamb Vedotin combined with pyrotinib
  other name: Regular Visits
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wei Li, Ph.D
  phone: 025-68307102
  email: real.lw@163.com
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No