<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/NCT03273595</url>
  </required_header>
  <id_info>
    <org_study_id>KY20162048-1</org_study_id>
    <nct_id>NCT03273595</nct_id>
  </id_info>
  <brief_title>Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive Breast Cancer</brief_title>
  <official_title>A Prospective, Open-label，Multicentre，Real-word Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy as Neoadjuvant Therapy for Women With HER2-positive and p95HER2-positive，PI3K Mutation，or PTEN Loss Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</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>
      This is a prospective, open-label, real-word study evaluating the efficacy and safety of&#xD;
      lapatinib in combination with chemotherapy versus trastuzumab in combination with&#xD;
      chemotherapy in women with HER2-positive and p95HER2-positive ,or PI3K mutation, or PTEN loss&#xD;
      breast cancer . Eligible subjects will have newly diagnosed breast cancer (Stage II-III) ;&#xD;
      not have received systemic or local treatment . The primary endpoint was the rate of&#xD;
      pathological complete response (pCR). The secondary objectives are to evaluate overall&#xD;
      survival, overall response rate, clinical benefit response rate and the safety as well as&#xD;
      tolerability of lapatinib plus chemotherapy and trastuzumab plus chemotherapy.&#xD;
&#xD;
      Patients will receive lapatinib 1000 mg daily or trastuzumab 4 mg/kg intravenous (IV) load&#xD;
      followed by 2 mg/kg IV weekly for a total of 12 weeks. After surgery, patients planned total&#xD;
      duration of the anti-HER2 therapy will be one year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pathological complete response (pCR)</measure>
    <time_frame>at the end of week 12</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Neoplasms, Breast</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lapatinib</intervention_name>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epirubicin</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female gender;&#xD;
&#xD;
          -  Age ≥18 years;&#xD;
&#xD;
          -  Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1&#xD;
&#xD;
          -  Histologically confirmed invasive breast cancer:&#xD;
&#xD;
          -  Primary tumour greater than 2 cm diameter, measured by clinical examination and&#xD;
             mammography or echography,&#xD;
&#xD;
          -  p95HER2 positive,or PI3K mutation,or PTEN loss&#xD;
&#xD;
          -  Over expression and/or amplification of HER2 in the invasive component of the primary&#xD;
             tumour [Wolff et al 2006] and confirmed by a certified laboratory prior to&#xD;
             randomisation&#xD;
&#xD;
          -  Known hormone receptor status.&#xD;
&#xD;
          -  Haematopoietic status:&#xD;
&#xD;
          -  Cardiovascular:&#xD;
&#xD;
          -  Baseline left ventricular ejection fraction (LVEF) ³ 50% measured by echocardiography&#xD;
             (ECHO) or Multiple Gate Acquisition (MUGA) scan,&#xD;
&#xD;
          -  Negative serum pregnancy test, within 2-weeks (preferably 7 days) prior to&#xD;
             randomization (For women of childbearing potential)&#xD;
&#xD;
          -  Fertile patients must use effective contraception (barrier method - condoms, diaphragm&#xD;
             - also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable,&#xD;
             or implant hormonal contraceptives are not allowed)&#xD;
&#xD;
          -  Signed informed consent form (ICF)&#xD;
&#xD;
          -  Patient accepts to make available tumour samples for submission to central laboratory&#xD;
             to conduct translational studies as part of this protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received any prior treatment for primary invasive breast cancer;&#xD;
&#xD;
          -  Previous (less than 10 years) or current history of malignant neoplasms, except for&#xD;
             curatively treated:&#xD;
&#xD;
          -  Basal and squamous cell carcinoma of the skin;&#xD;
&#xD;
          -  Carcinoma in situ of the cervix.&#xD;
&#xD;
          -  Patients with a prior malignancy diagnosed more than 10 years prior to randomisation&#xD;
             may enter the study. Patients must have been curatively treated with surgery alone.&#xD;
             Radiation therapy or systemic therapy (chemotherapy or endocrine) are NOT permitted.&#xD;
             Prior diagnoses of breast cancer or melanoma are excluded.&#xD;
&#xD;
          -  Diagnosis of inflammatory breast cancer;&#xD;
&#xD;
          -  Bilateral cancer;&#xD;
&#xD;
          -  This criterion has been deleted from the protocol Version 1. Patients with multi-focal&#xD;
             cancer are no longer excluded.&#xD;
&#xD;
          -  Known history of uncontrolled or symptomatic angina, clinically significant&#xD;
             arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled&#xD;
             hypertension (≥180/110), unstable diabetes mellitus, dyspnoea at rest, or chronic&#xD;
             therapy with oxygen;&#xD;
&#xD;
          -  Concurrent disease or condition that would make the subject inappropriate for study&#xD;
             participation or any serious medical disorder that would interfere with the subject's&#xD;
             safety;&#xD;
&#xD;
          -  Unresolved or unstable, serious adverse events from prior administration of another&#xD;
             investigational drug;&#xD;
&#xD;
          -  Active or uncontrolled infection;&#xD;
&#xD;
          -  Dementia, altered mental status, or any psychiatric condition that would prevent the&#xD;
             understanding or rendering of ICF;&#xD;
&#xD;
          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or&#xD;
             resection of the stomach or small bowel. Subjects with ulcerative colitis are also&#xD;
             excluded;&#xD;
&#xD;
          -  Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy,&#xD;
             biologic therapy other than the trial therapies);&#xD;
&#xD;
          -  Concurrent treatment with an investigational agent or participation in another&#xD;
             therapeutic clinical trial;&#xD;
&#xD;
          -  Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs&#xD;
             chemically related to trastuzumab or lapatinib or their excipients;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Concomitant use of CYP3A4 inhibitors or inducers&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rui Ling, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xijing Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rui Ling, Doctor</last_name>
    <phone>+862984775271</phone>
    <email>lingrui0105@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juliang Zhang, Doctor</last_name>
    <phone>+862984775271</phone>
    <email>zhangjl@fmmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juliang Zhang, Doctor</last_name>
      <phone>+862984775271</phone>
      <email>zhangjl@fmmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Juliang Zhang, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>February 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</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>Cyclophosphamide</mesh_term>
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Epirubicin</mesh_term>
    <mesh_term>Lapatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03273595
org study id: KY20162048-1
nct id: NCT03273595
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, open-label, real-word study evaluating the efficacy and safety of
      lapatinib in combination with chemotherapy versus trastuzumab in combination with
      chemotherapy in women with HER2-positive and p95HER2-positive ,or PI3K mutation, or PTEN loss
      breast cancer . Eligible subjects will have newly diagnosed breast cancer (Stage II-III) ;
      not have received systemic or local treatment . The primary endpoint was the rate of
      pathological complete response (pCR). The secondary objectives are to evaluate overall
      survival, overall response rate, clinical benefit response rate and the safety as well as
      tolerability of lapatinib plus chemotherapy and trastuzumab plus chemotherapy.

      Patients will receive lapatinib 1000 mg daily or trastuzumab 4 mg/kg intravenous (IV) load
      followed by 2 mg/kg IV weekly for a total of 12 weeks. After surgery, patients planned total
      duration of the anti-HER2 therapy will be one year.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pathological complete response (pCR)
time frame: at the end of week 12
arm group label: Control
arm group type: Placebo Comparator
arm group label: Experimental group
arm group type: Experimental
intervention type: Drug
intervention name: Lapatinib
arm group label: Experimental group
intervention type: Biological
intervention name: Trastuzumab
arm group label: Control
intervention type: Drug
intervention name: Paclitaxel
arm group label: Control
arm group label: Experimental group
intervention type: Drug
intervention name: Epirubicin
arm group label: Control
arm group label: Experimental group
intervention type: Drug
intervention name: Cyclophosphamide
arm group label: Control
arm group label: Experimental group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rui Ling, Doctor
role: Principal Investigator
affiliation: Xijing Hospital
last name: Rui Ling, Doctor
phone: +862984775271
email: lingrui0105@163.com
last name: Juliang Zhang, Doctor
phone: +862984775271
email: zhangjl@fmmu.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Paclitaxel
mesh term: Cyclophosphamide
mesh term: Trastuzumab
mesh term: Epirubicin
mesh term: Lapatinib
sharing ipd: Yes