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/NCT06035679</url>
    </required_header>
    <id_info>
      <org_study_id>OBU-BC-II-95</org_study_id>
      <nct_id>NCT06035679</nct_id>
    </id_info>
    <brief_title>Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer</brief_title>
    <official_title>Prospective, Single-center, Observational Clinical Study of Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Youzhi Zhu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital of Fujian Medical University</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 prospective, single-center, observational clinical study, The objection was&#xD;
        to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy&#xD;
        Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down&#xD;
        neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, single-center, observational clinical study,Which plan to be&#xD;
        enroll 30 patients with HER2-positive early breast cancer receive pyrotinib combined with&#xD;
        trastuzumab and chemotherapy neoadjuvant therapy. The primary endpoint was the total&#xD;
        pathological complete response rate (tpCR) , The objection was to observe the treatment of&#xD;
        pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III&#xD;
        breast cancer and observation of the efficacy of step-down neoadjuvant therapy for&#xD;
        HER2-positive stage T1cN0M0 breast cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2026</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>tpCR</measure>
      <time_frame>at surgery</time_frame>
      <description>total Pathological Complete Response</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Breast Cancer Female</condition>
    <arm_group>
      <arm_group_label>Pyrotinib Combined With Trastuzumab and Chemotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>T1cN0M0 HER2+ breast cancer Patients received 2 cycles (pyrotinib + trastuzumab + taxoid) regimen and were evaluated to continue with the original regimen if PR, and 4 cycles (pyrotinib + trastuzumab + taxoid + carboplatin) regimen if SD/PD. Phase II-III HER2+ breast cancer Patients received 6 cycles of treatment (pyrotinib + trastuzumab + taxoid + carboplatin)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pyrotinib and Trastuzumab</intervention_name>
      <description>Small and large molecules combined with chemotherapy for neoadjuvant treatment of HER2-positive breast cancer</description>
      <arm_group_label>Pyrotinib Combined With Trastuzumab and Chemotherapy</arm_group_label>
      <other_name>dual HER2 blockade in the neoadjuvant setting</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Female patients aged 18-75 years;&#xD;
  &#xD;
            2. Her2-positive breast cancer confirmed by pathology;&#xD;
  &#xD;
            3. invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1,&#xD;
               M0) or locally advanced stage (T2-4, N2, N3, M0);&#xD;
  &#xD;
            4. ECOG PS: 0-1 score;&#xD;
  &#xD;
            5. Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving&#xD;
               surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node&#xD;
               dissection (ALND)&#xD;
  &#xD;
            6. Normal function of major organs means that the following criteria are met:&#xD;
  &#xD;
          (1) Blood test neutrophil (ANC) &gt;=1.5x10^9/L; Platelet count (PLT) &gt;=90x10^9/L; Hemoglobin&#xD;
          (Hb) &gt;=90g/L; (2) Total bilirubin (TBIL) &lt;=1.5 upper limit of normal (ULN); Alanine&#xD;
          aminotransferase (ALT) and aspartate aminotransferase (AST) &lt;=1.5xULN; Alkaline phosphatase&#xD;
          &lt;=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) &lt;=1.5xULN; (3) Left ventricular ejection&#xD;
          fraction (LVEF) &gt;=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less&#xD;
          than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical&#xD;
          sterilization: consent to abstinence or use an effective contraceptive method (during&#xD;
          treatment and for at least 7 months after the last dose in the study treatment); 8.&#xD;
          Volunteer to participate in this study, sign the informed consent, have good compliance and&#xD;
          be willing to cooperate with follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known allergic history of the drug components of this protocol;&#xD;
  &#xD;
            2. Previous or co-existing other malignant tumors, except cured basal cell carcinoma of&#xD;
               the skin and carcinoma in situ of the cervix;&#xD;
  &#xD;
            3. Participated in clinical trials of other antitumor drugs within four weeks;&#xD;
  &#xD;
            4. Stage IV (metastatic) breast cancer;&#xD;
  &#xD;
            5. Multiple factors affecting oral medication (e.g., inability to swallow,&#xD;
               post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);&#xD;
  &#xD;
            6. A history of congestive heart failure (CHF) or uncontrolled heart disease (angina,&#xD;
               arrhythmia, hypertension);&#xD;
  &#xD;
            7. Patients with active infection and severe mental illness;&#xD;
  &#xD;
            8. Pregnant or lactating patients;&#xD;
  &#xD;
            9. Patients with allergies or known history of allergies to the drug components of this&#xD;
               protocol; A history of immunodeficiency, including being HIV positive, or having other&#xD;
               acquired or congenital immunodeficiency diseases, or a history of organ&#xD;
               transplantation;&#xD;
  &#xD;
           10. Concomitant diseases that, in the judgment of the investigator, seriously endanger the&#xD;
               patient's safety or interfere with the patient's completion of the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>zhu youzhi</last_name>
      <role>Study Chair</role>
      <affiliation>First Affiliated Hospital of Fujian Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>zhu youzhi</last_name>
      <phone>17759120588</phone>
      <email>zhu@fjmu.edu.cn</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>First Affiliated Hospital of Fujian Medical University</investigator_affiliation>
      <investigator_full_name>Youzhi Zhu</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </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>Trastuzumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is not a plan to make IPD available</ipd_description>
    </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/NCT06035679
  org study id: OBU-BC-II-95
  nct id: NCT06035679
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a prospective, single-center, observational clinical study, The objection was
        to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy
        Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down
        neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.
  This study is a prospective, single-center, observational clinical study,Which plan to be
        enroll 30 patients with HER2-positive early breast cancer receive pyrotinib combined with
        trastuzumab and chemotherapy neoadjuvant therapy. The primary endpoint was the total
        pathological complete response rate (tpCR) , The objection was to observe the treatment of
        pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III
        breast cancer and observation of the efficacy of step-down neoadjuvant therapy for
        HER2-positive stage T1cN0M0 breast cancer.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: tpCR
  time frame: at surgery
  description: total Pathological Complete Response
  arm group label: Pyrotinib Combined With Trastuzumab and Chemotherapy
  arm group type: Experimental
  description: T1cN0M0 HER2+ breast cancer Patients received 2 cycles (pyrotinib + trastuzumab + taxoid) regimen and were evaluated to continue with the original regimen if PR, and 4 cycles (pyrotinib + trastuzumab + taxoid + carboplatin) regimen if SD/PD. Phase II-III HER2+ breast cancer Patients received 6 cycles of treatment (pyrotinib + trastuzumab + taxoid + carboplatin)
  intervention type: Drug
  intervention name: Pyrotinib and Trastuzumab
  description: Small and large molecules combined with chemotherapy for neoadjuvant treatment of HER2-positive breast cancer
  arm group label: Pyrotinib Combined With Trastuzumab and Chemotherapy
  other name: dual HER2 blockade in the neoadjuvant setting
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: zhu youzhi
  role: Study Chair
  affiliation: First Affiliated Hospital of Fujian Medical University
  last name: zhu youzhi
  phone: 17759120588
  email: zhu@fjmu.edu.cn
  responsible party type: Sponsor-Investigator
  investigator affiliation: First Affiliated Hospital of Fujian Medical University
  investigator full name: Youzhi Zhu
  investigator title: Clinical Professor
  mesh term: Breast Neoplasms
  mesh term: Trastuzumab
  sharing ipd: No
  ipd description: There is not a plan to make IPD available