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/NCT06000917</url>
    </required_header>
    <id_info>
      <org_study_id>UHCT22745</org_study_id>
      <nct_id>NCT06000917</nct_id>
    </id_info>
    <brief_title>A Study of Neoadjuvant TCHpy（Pyrotinib ，Trastuzumab，Carboplatin and Paclitaxel）for ER+/HER2+ Breast Cancer</brief_title>
    <official_title>A Multicenter, Single-arm, Prospective Study of Neoadjuvant Pyrotinib Combined With Trastuzumab，Carboplatin and Paclitaxel for ER+/HER2+ Early or Locally Advanced Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wuhan Union Hospital, China</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 multicenter, single-arm, prospective, open clinical study to evaluate the&#xD;
        efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and&#xD;
        carboplatin in neoadjuvant therapy for ER+/HER2+ early or locally advanced breast cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 11, 2023</start_date>
    <completion_date type="Anticipated">May 11, 2028</completion_date>
    <primary_completion_date type="Anticipated">May 11, 2025</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>total Pathological Complete Response(tPCR)</measure>
      <time_frame>2 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>breast Pathological Complete Response(bPCR)</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>overall response rate(ORR)</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>event-free survival(EFS)</measure>
      <time_frame>5 years</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">62</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Neoadjuvant</condition>
    <arm_group>
      <arm_group_label>pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Pyrotinib tablets: 320mg qd, 21 days for 1 cycle, continuous administration of 6 cycles.&#xD;
  Trastuzumab: The first cycle was 8mg/kg, the second to sixth cycle was 6mg/kg, 21 days was 1 cycle, continuous administration of 6 cycles.&#xD;
  Albuminpaclitaxel: On the first day of cycle 1, 260mg/m2 was given intravenously, 21 days for 1 cycle, and 6 consecutive cycles were given.&#xD;
  Carboplatin: Endogenous creatinine clearance was calculated using the Cockcroft formula, with AUC 5 for the 1st to 6th cycle and 1 cycle for the 21st day and 6 consecutive cycles of administration</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel</intervention_name>
      <description>Pyrotinib tablets: 320mg qd, oral administration after breakfast, 21 days for 1 cycle, continuous administration of 6 cycles.&#xD;
  Trastuzumab: The first cycle was 8mg/kg, the second to sixth cycle was 6mg/kg, 21 days was 1 cycle, continuous administration of 6 cycles.&#xD;
  Albuminpaclitaxel: On the first day of cycle 1, 260mg/m2 was given intravenously, 21 days for 1 cycle, and 6 consecutive cycles were given.&#xD;
  Carboplatin: Endogenous creatinine clearance was calculated using the Cockcroft formula, with AUC 5 for the 1st to 6th cycle and 1 cycle for the 21st day and 6 consecutive cycles of administration</description>
      <arm_group_label>pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Newly treated female patients aged ≥18 years and ≤75 years;&#xD;
  &#xD;
            -  ECOG score 0~1;&#xD;
  &#xD;
            -  Pathologically diagnosed as HER2-positive breast cancer patients with early or locally&#xD;
               advanced tumor stage, primary tumor diameter T≥2cm or lymph node positive;&#xD;
  &#xD;
            -  Hormone receptor status (ER and PgR) is known, where ER≥10%&#xD;
  &#xD;
            -  Normal function of major organs:&#xD;
  &#xD;
                 1. The standard of blood routine examination should meet: ANC ≥1.5×109/L;&#xD;
                    PLT≥90×109/L; Hb ≥90g/L&#xD;
  &#xD;
                 2. Biochemical examination should meet the following standards: TBIL≤ the upper&#xD;
                    limit of normal value(ULN); ALT and AST≤1.5 times the upper limit of normal&#xD;
                    (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); BUN and&#xD;
                    Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula);&#xD;
  &#xD;
                 3. Cardiac color ultrasound and echocardiography: left ventricular ejection&#xD;
                    fraction(LVEF≥55%)&#xD;
  &#xD;
                 4. Fridericia calibrated QT interval (QTcF) for 18-lead ECG &lt;470 ms;&#xD;
  &#xD;
            -  For female patients who are not menopausal or have not been surgically sterilized:&#xD;
               consent to abstinence or use of an effective contraceptive method during treatment and&#xD;
               for at least 7 months after the last dose in the study treatment;&#xD;
  &#xD;
            -  Volunteer to join the study and sign the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Stage IV (metastatic) breast cancer;&#xD;
  &#xD;
            -  Inflammatory breast cancer;&#xD;
  &#xD;
            -  Previous antitumor therapy or radiation therapy for any malignancies, excluding cured&#xD;
               cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma;&#xD;
  &#xD;
            -  Also receiving antitumor therapy in other clinical trials, including endocrine&#xD;
               therapy, bisphosphonate therapy, or immunotherapy;&#xD;
  &#xD;
            -  Had a major surgery not related to breast cancer in the 4 weeks prior to enrollment,&#xD;
               or had not fully recovered from such surgery;&#xD;
  &#xD;
            -  Serious heart disease or discomfort, including but not limited to the following:&#xD;
  &#xD;
                 -  History of heart failure or systolic dysfunction (LVEF &lt; 50%)&#xD;
  &#xD;
                 -  High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart&#xD;
                    rate &gt;100 bpm, significant ventricular arrhythmias (such as ventricular&#xD;
                    tachycardia), or higher-grade atrioventricular block (i.e. Mobitz II second-&#xD;
                    degree atrioventricular block or third-degree atrioventricular block&#xD;
  &#xD;
            -  Inability to swallow, intestinal obstruction, or other factors affecting the use and&#xD;
               absorption of the drug;&#xD;
  &#xD;
            -  Known allergic history of the drug components of this protocol; A history of&#xD;
               immunodeficiency, including HIV testing positive, or other acquired, congenital&#xD;
               immunodeficiency diseases, or a history of organ transplantation;&#xD;
  &#xD;
            -  Women who are pregnant or nursing, women who are fertile and have a positive baseline&#xD;
               pregnancy test, or women of childbearing age who are unwilling to use effective&#xD;
               contraception throughout the trial period and within 7 months after the last study&#xD;
               medication;&#xD;
  &#xD;
            -  Have a serious concomitant condition or other comorbid condition that interferes with&#xD;
               planned treatment, or any other condition in which the investigator deems the patient&#xD;
               unsuitable for participation in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yao Jing</last_name>
      <phone>13971139665</phone>
      <email>jeaneyph@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>WuhanHU</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jing Yao</last_name>
        <phone>02785726375</phone>
        <email>jeaneyph@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yao Jing</last_name>
        <phone>13971139665</phone>
        <email>jeaneyph@163.com</email>
      </contact>
    </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 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>
    <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>Carboplatin</mesh_term>
      <mesh_term>Trastuzumab</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/NCT06000917
  org study id: UHCT22745
  nct id: NCT06000917
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a multicenter, single-arm, prospective, open clinical study to evaluate the
        efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and
        carboplatin in neoadjuvant therapy for ER+/HER2+ early or locally advanced breast cancer.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: total Pathological Complete Response(tPCR)
  time frame: 2 years
  measure: breast Pathological Complete Response(bPCR)
  time frame: 2 years
  measure: overall response rate(ORR)
  time frame: 2 years
  measure: event-free survival(EFS)
  time frame: 5 years
  arm group label: pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel
  arm group type: Experimental
  description: Pyrotinib tablets: 320mg qd, 21 days for 1 cycle, continuous administration of 6 cycles.
  Trastuzumab: The first cycle was 8mg/kg, the second to sixth cycle was 6mg/kg, 21 days was 1 cycle, continuous administration of 6 cycles.
  Albuminpaclitaxel: On the first day of cycle 1, 260mg/m2 was given intravenously, 21 days for 1 cycle, and 6 consecutive cycles were given.
  Carboplatin: Endogenous creatinine clearance was calculated using the Cockcroft formula, with AUC 5 for the 1st to 6th cycle and 1 cycle for the 21st day and 6 consecutive cycles of administration
  intervention type: Drug
  intervention name: pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel
  description: Pyrotinib tablets: 320mg qd, oral administration after breakfast, 21 days for 1 cycle, continuous administration of 6 cycles.
  Trastuzumab: The first cycle was 8mg/kg, the second to sixth cycle was 6mg/kg, 21 days was 1 cycle, continuous administration of 6 cycles.
  Albuminpaclitaxel: On the first day of cycle 1, 260mg/m2 was given intravenously, 21 days for 1 cycle, and 6 consecutive cycles were given.
  Carboplatin: Endogenous creatinine clearance was calculated using the Cockcroft formula, with AUC 5 for the 1st to 6th cycle and 1 cycle for the 21st day and 6 consecutive cycles of administration
  arm group label: pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Yao Jing
  phone: 13971139665
  email: jeaneyph@163.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Paclitaxel
  mesh term: Carboplatin
  mesh term: Trastuzumab
  sharing ipd: No