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/NCT06035016</url>
    </required_header>
    <id_info>
      <org_study_id>aPC-BC</org_study_id>
      <nct_id>NCT06035016</nct_id>
    </id_info>
    <brief_title>Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer</brief_title>
    <official_title>A Prospective, Multicenter and Registry-based Cohort Study of Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College 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, registry-based cohort study to explore the efficacy and&#xD;
        safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early&#xD;
        breast cancer compared with treatment of physician's choice. Pyrotinib is a small molecule&#xD;
        tyrosine kinase inhibitor which can irreversibly inhibit HER1, HER2, and HER4.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2027</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>3-year IDFS</measure>
      <time_frame>3 Year</time_frame>
      <description>The 3-year IDFS (invasive disease-free survival) is defined as the time from the date of enrollment to the first occurrence of recurrent diseases. Recurrent diseases include ipsilateral or contralateral recurrent breast cancer, local or regional recurrence, remote recurrence and death caused by any reason. The observation period is from enrollment to 3 years after enrollment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>AEs and SAEs</measure>
      <time_frame>3 Year</time_frame>
      <description>The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) are recorded according to the NCI CTCAE v5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QoL</measure>
      <time_frame>3 Year</time_frame>
      <description>The quality of life (QoL) of the participants is assessed according to the EORTC QLQ-C30 quality of life questionnaire.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>HER2-positive Breast Cancer</condition>
    <condition>Early-stage Breast Cancer</condition>
    <arm_group>
      <arm_group_label>cohort A</arm_group_label>
      <description>Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w</description>
    </arm_group>
    <arm_group>
      <arm_group_label>cohort B</arm_group_label>
      <description>treatment of physician's choice</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>pyrotinib combined with Capecitabine</intervention_name>
      <description>Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w</description>
      <arm_group_label>cohort A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>treatment of physician's choice</intervention_name>
      <description>Treatment of physician's choice</description>
      <arm_group_label>cohort B</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          HER2 positive early-stage breast cancer patients expected to receive adjuvant treatment&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Female patients ≥ 18 years and ≤ 75 years old;&#xD;
  &#xD;
            2. Primary invasive breast cancer confirmed by histology;&#xD;
  &#xD;
            3. HER2 positive breast cancer (IHC 3+, or IHC 2+ and FISH positive); lymph node&#xD;
               positive, except for T0; lymph node negative and tumor &gt;1cm, or tumor &gt; 0.5 cm and ≤&#xD;
               1cm, and accompanied by any of the following high-risk factors: pathological grade 3,&#xD;
               ER/PR negative, or &lt; 35 years old;&#xD;
  &#xD;
            4. Having received mastectomy or breast conserving surgery, and received sentinel lymph&#xD;
               node biopsy or axillary lymph node dissection, and within 90 days from the breast&#xD;
               surgery;&#xD;
  &#xD;
            5. With known ER/PR status of breast cancer;&#xD;
  &#xD;
            6. ECOG score 0-1;&#xD;
  &#xD;
            7. The patient's major organ functions meet all of the following requirements for blood&#xD;
               tests:&#xD;
  &#xD;
                 1. Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);&#xD;
  &#xD;
                 2. Platelet count (PLT) ≥ 75,000/mm3 (75×109/L);&#xD;
  &#xD;
                 3. Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);&#xD;
  &#xD;
                 4. Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine&#xD;
                    clearance ≥ 60 mL/min;&#xD;
  &#xD;
                 5. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);&#xD;
  &#xD;
                 6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5&#xD;
                    times the upper limit of normal (ULN), patients with liver metastases should be ≤&#xD;
                    5×ULN.&#xD;
  &#xD;
          9. The participant voluntarily joins the study, signs the informed consent form, has good&#xD;
          compliance, and cooperates with follow-ups.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Breast cancer recurs before enrollment, or local recurrence/ metastasis confirmed by&#xD;
               radiology;&#xD;
  &#xD;
            2. The subject has participated in other clinical trials within 4 weeks or 5 half-lives&#xD;
               (whichever is longer) before enrollment;&#xD;
  &#xD;
            3. The patient has previously received treatment including tyrosine kinase inhibitors&#xD;
               targeting HER2 (e.g., lapatinib, neratinib, and pyrotinib);&#xD;
  &#xD;
            4. The patient has been diagnosed with other malignancies within 5 years of enrollment,&#xD;
               except for cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous&#xD;
               cell carcinoma of the skin which has been cured;&#xD;
  &#xD;
            5. The patient is receiving anti-tumor therapies from other clinical trials;&#xD;
  &#xD;
            6. Inability to swallow, chronic diarrhea, or intestinal obstruction, with multiple&#xD;
               factors affecting drug administration and absorption;&#xD;
  &#xD;
            7. The patient has undergone major surgical procedures unrelated to breast cancer within&#xD;
               4 weeks of enrollment, or has not fully recovered from such surgical procedures;&#xD;
  &#xD;
            8. With known allergies to any components of the agents to be administered in this study;&#xD;
               history of acquired or congenital immunodeficiency diseases, including HIV; history of&#xD;
               HCV, active hepatitis B, or history of organ transplantation;&#xD;
  &#xD;
            9. Pregnant and lactating patients, patients of fertility unwilling to take effective&#xD;
               contraceptive measures throughout the trial;&#xD;
  &#xD;
           10. With any heart disease including: (1) arrhythmia requiring medication or clinical&#xD;
               attention; (2) myocardial infarction; (3) heart failure; (4) any other heart diseases&#xD;
               that are considered unsuitable to the trial;&#xD;
  &#xD;
           11. With any comorbidities that are considered to potentially endanger the patient's&#xD;
               safety or interfere with the study, including but not restricted to resistant&#xD;
               hypertension, severe diabetes, active infection, etc.;&#xD;
  &#xD;
           12. With a history of neurological or mental disorders, including but not restricted to&#xD;
               epilepsy or dementia;&#xD;
  &#xD;
           13. The patient is using CYP3A4 inhibitors or inducers, or any other drugs that&#xD;
               potentially prolong the QT interval;&#xD;
  &#xD;
           14. Any other circumstances in which the researcher believes that the patient is not&#xD;
               suitable to participate in this 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>Xuefei Wang</last_name>
      <phone>861069158720</phone>
      <email>1210548954@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xuefei Wang, Dr.</last_name>
        <phone>861069158720</phone>
        <email>1210548954@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
      <investigator_full_name>Qiang SUN</investigator_full_name>
      <investigator_title>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>Capecitabine</mesh_term>
    </intervention_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/NCT06035016
  org study id: aPC-BC
  nct id: NCT06035016
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, multicenter, registry-based cohort study to explore the efficacy and
        safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early
        breast cancer compared with treatment of physician's choice. Pyrotinib is a small molecule
        tyrosine kinase inhibitor which can irreversibly inhibit HER1, HER2, and HER4.
  observational model: Cohort
  time perspective: Prospective
  measure: 3-year IDFS
  time frame: 3 Year
  description: The 3-year IDFS (invasive disease-free survival) is defined as the time from the date of enrollment to the first occurrence of recurrent diseases. Recurrent diseases include ipsilateral or contralateral recurrent breast cancer, local or regional recurrence, remote recurrence and death caused by any reason. The observation period is from enrollment to 3 years after enrollment.
  measure: AEs and SAEs
  time frame: 3 Year
  description: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) are recorded according to the NCI CTCAE v5.0.
  measure: QoL
  time frame: 3 Year
  description: The quality of life (QoL) of the participants is assessed according to the EORTC QLQ-C30 quality of life questionnaire.
  arm group label: cohort A
  description: Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w
  arm group label: cohort B
  description: treatment of physician's choice
  intervention type: Drug
  intervention name: pyrotinib combined with Capecitabine
  description: Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w
  arm group label: cohort A
  intervention type: Drug
  intervention name: treatment of physician's choice
  description: Treatment of physician's choice
  arm group label: cohort B
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xuefei Wang
  phone: 861069158720
  email: 1210548954@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking Union Medical College Hospital
  investigator full name: Qiang SUN
  investigator title: Professor
  mesh term: Breast Neoplasms
  mesh term: Capecitabine
  sharing ipd: Undecided