<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/NCT03756064</url>
  </required_header>
  <id_info>
    <org_study_id>TCHP</org_study_id>
    <nct_id>NCT03756064</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer</brief_title>
  <official_title>Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Docetaxel and Carboplatin in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer: a Single-arm, Ahead, Open-label Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang Cancer Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy&#xD;
      and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus&#xD;
      placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2&#xD;
      positive early stage or locally advanced breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+&#xD;
      Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control&#xD;
      group (Placebo +Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.&#xD;
&#xD;
      It is proposed that 100 participants will be enrolled in this study. The target population is&#xD;
      women with early breast cancer (stage of T1-4N0-3M0) who are eligible for primary systemic&#xD;
      therapy.&#xD;
&#xD;
      The primary objective of the trial is to determine the pCR rate. The secondary objective of&#xD;
      the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance&#xD;
      Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Experimental: Pyrotinib (400mg orally daily)+Trastuzumab (8mg/kg iv load followed by 6mg/kg iv 3-weekly)+Docetaxel (75mg/m2)+ Carboplatin(AUC=5), for a total of 6 cycles.&#xD;
Placebo Comparator: Placebo Oral Tablet (400mg orally daily)+Trastuzumab (8mg/kg iv load followed by 6mg/kg iv 3-weekly)+Docetaxel (75mg/m2)+ Carboplatin(AUC=5), for a total of 6 cycles.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pCR</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EFS</measure>
    <time_frame>Following surgery until Year 3</time_frame>
    <description>Event-free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DFS</measure>
    <time_frame>Following surgery until Year 3</time_frame>
    <description>Disease-free Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DDFS</measure>
    <time_frame>Following surgery until Year 3</time_frame>
    <description>Distance Disease-free Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months</time_frame>
    <description>Objective Response Rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Neoplasm, Breast</condition>
  <condition>Breast Diseases</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pyrotinib+Trastuzumab+Docetaxel +Carboplatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pyrotinib</intervention_name>
    <description>Pyrotinib: 400mg orally daily</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <description>Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles;</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Docetaxel: 75mg/m2 for a total of 6 cycles</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin: AUC=5 for a total of 6 cycles</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo Oral Tablet: 400mg orally daily</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. female patients, 18 years ≤ age ≤ 80 years；&#xD;
&#xD;
          2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1&#xD;
&#xD;
          3. Histologically confirmed invasive breast cancer（early stage or locally advanced）&#xD;
&#xD;
          4. HER2 positive (HER2+++ by IHC or FISH+)&#xD;
&#xD;
          5. Known hormone receptor status.&#xD;
&#xD;
          6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by&#xD;
             ECHO&#xD;
&#xD;
          7. Signed informed consent form (ICF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Metastatic disease (Stage IV) or inflammatory breast cancer&#xD;
&#xD;
          2. Previous or current history of malignant neoplasms, except for curatively treated:&#xD;
             Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.&#xD;
&#xD;
          3. Clinically relevant cardiovascular disease: Known history of uncontrolled or&#xD;
             symptomatic angina, clinically significant arrhythmias, congestive heart failure,&#xD;
             transmural myocardial infarction, uncontrolled hypertension ≥180/110);&#xD;
&#xD;
          4. Unable or unwilling to swallow tablets.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ding Xiaowen, DR.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ding Xiaowen, DR.</last_name>
    <phone>+86 13588054604</phone>
    <email>dingxw@zjcc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ding Yuqin</last_name>
    <phone>+86 13588255651</phone>
    <email>13588255651@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xiaowen ding, Dr.</last_name>
      <phone>+8613588054604</phone>
      <email>dingxw@zjcc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>August 8, 2019</last_update_submitted>
  <last_update_submitted_qc>August 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</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>
    <mesh_term>Breast Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Trastuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03756064
org study id: TCHP
nct id: NCT03756064
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy
      and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus
      placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2
      positive early stage or locally advanced breast cancer.
The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+
      Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control
      group (Placebo +Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.

      It is proposed that 100 participants will be enrolled in this study. The target population is
      women with early breast cancer (stage of T1-4N0-3M0) who are eligible for primary systemic
      therapy.

      The primary objective of the trial is to determine the pCR rate. The secondary objective of
      the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance
      Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental: Pyrotinib (400mg orally daily)+Trastuzumab (8mg/kg iv load followed by 6mg/kg iv 3-weekly)+Docetaxel (75mg/m2)+ Carboplatin(AUC=5), for a total of 6 cycles.
Placebo Comparator: Placebo Oral Tablet (400mg orally daily)+Trastuzumab (8mg/kg iv load followed by 6mg/kg iv 3-weekly)+Docetaxel (75mg/m2)+ Carboplatin(AUC=5), for a total of 6 cycles.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: pCR
time frame: through study completion, an average of 1 year
description: Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
measure: EFS
time frame: Following surgery until Year 3
description: Event-free survival
measure: DFS
time frame: Following surgery until Year 3
description: Disease-free Survival
measure: DDFS
time frame: Following surgery until Year 3
description: Distance Disease-free Survival
measure: ORR
time frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
description: Objective Response Rate
arm group label: Experimental group
arm group type: Experimental
description: Pyrotinib+Trastuzumab+Docetaxel +Carboplatin
arm group label: Control group
arm group type: Placebo Comparator
description: Placebo Oral Tablet+Trastuzumab+Docetaxel +Carboplatin
intervention type: Drug
intervention name: Pyrotinib
description: Pyrotinib: 400mg orally daily
arm group label: Experimental group
intervention type: Drug
intervention name: Trastuzumab
description: Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles;
arm group label: Control group
arm group label: Experimental group
intervention type: Drug
intervention name: Docetaxel
description: Docetaxel: 75mg/m2 for a total of 6 cycles
arm group label: Control group
arm group label: Experimental group
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin: AUC=5 for a total of 6 cycles
arm group label: Control group
arm group label: Experimental group
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo Oral Tablet: 400mg orally daily
arm group label: Control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ding Xiaowen, DR.
role: Principal Investigator
affiliation: Zhejiang Cancer Hospital
last name: Ding Xiaowen, DR.
phone: +86 13588054604
email: dingxw@zjcc.org.cn
last name: Ding Yuqin
phone: +86 13588255651
email: 13588255651@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Breast Diseases
mesh term: Carboplatin
mesh term: Docetaxel
mesh term: Trastuzumab
sharing ipd: Undecided