<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/NCT03786107</url>
  </required_header>
  <id_info>
    <org_study_id>PUMA-NER-9501</org_study_id>
    <nct_id>NCT03786107</nct_id>
  </id_info>
  <brief_title>HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib</brief_title>
  <official_title>HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Puma Biotechnology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Puma Biotechnology, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, observational genomic screening protocol to identify participants&#xD;
      whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating&#xD;
      tumor DNA (ctDNA) . Participants with histologically confirmed, hormone receptor positive,&#xD;
      HER-2 negative, metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are&#xD;
      eligible for screening at 6 months intervals, or if disease progression is&#xD;
      suspected/confirmed. Blood samples will be collected from eligible participants and ctDNA&#xD;
      will be extracted and sequenced at a central laboratory, using a HER2-targeted next&#xD;
      generation sequencing (NGS) test. A certified molecular test report will be issued from the&#xD;
      central laboratory and provided to the investigators and the study sponsor. Participants who&#xD;
      are identified with HER2 mutations by this screening protocol will subsequently have access&#xD;
      to an appropriate neratinib treatment protocol, pending medical eligibility.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was stopped early due to increased global access to genomic screening. It is no&#xD;
    longer economical to continue with this particular single-gene screening protocol.&#xD;
  </why_stopped>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Actual">January 21, 2021</completion_date>
  <primary_completion_date type="Actual">January 21, 2021</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>Number of Participants Eligible for Neratinib Treatment</measure>
    <time_frame>From enrollment date to identification of HER2 positive mutation, assessed up to five years</time_frame>
    <description>Identification of participants with somatic, activating HER2 mutations who might qualify for enrollment into neratinib treatment protocols</description>
  </primary_outcome>
  <enrollment type="Actual">1583</enrollment>
  <condition>Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer</condition>
  <condition>Metastatic Cervical Cancer</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Almac HER-Seq Assay</intervention_name>
    <description>whole blood sample analysis</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Circulating tumor DNA from plasma will be collected from eligible participants. ERBB2 (HER2)&#xD;
      gene exons 8 and 17-24 will be sequenced by next generation sequencing (NGS) at a central&#xD;
      laboratory.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with histologically-confirmed metastatic breast or metastatic cervical cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women and men who are ≥18 years old at signing of informed consent&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) status of 0 to 2&#xD;
&#xD;
          -  Provide written informed consent to participate in the study and for circulating tumor&#xD;
             DNA screening&#xD;
&#xD;
          -  Must be able to provide blood sample(s) for HER2 mutation testing&#xD;
&#xD;
          -  Participants with imaging or histologically confirmed, HR-positive, HER2-negative MBC&#xD;
             who are presently receiving or have received CDK4/6 inhibitor as a prior therapy in&#xD;
             any setting, or participants with imaging or histologically confirmed metastatic&#xD;
             cervical cancer&#xD;
&#xD;
          -  At least one measurable lesion, as defined by RECIST v1.1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with breast cancer with known HER2-positive or HER2-amplified tumors&#xD;
&#xD;
          -  Participants with breast cancer with HR-negative tumors&#xD;
&#xD;
          -  Participants who have received HER2-directed TKI&#xD;
&#xD;
          -  Participants with previously documented somatic KRAS activating mutation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Senior Vice President Clinical Science and Pharmacology</last_name>
    <role>Study Director</role>
    <affiliation>Puma Biotechnology, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magee-Womens Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Saint-Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cork University Hospital</name>
      <address>
        <city>Wilton</city>
        <state>Cork</state>
        <zip>T12 DC4A</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's University Hospital</name>
      <address>
        <city>Elm Park</city>
        <state>Dublin</state>
        <zip>D04 T6F4</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Misericordiae University Hospital, Institute for Cancer Research</name>
      <address>
        <city>Dublin</city>
        <zip>D07 R2WY</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital, Cancer Clinical Trials &amp; Research Unit</name>
      <address>
        <city>Dublin</city>
        <zip>D09 V2N0</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Waterford, Department of Medical Oncology</name>
      <address>
        <city>Waterford</city>
        <zip>X91 ER8E</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center, Davidoff Cancer Center</name>
      <address>
        <city>Petah tikva</city>
        <state>Central</state>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center</name>
      <address>
        <city>Reẖovot</city>
        <state>Central</state>
        <zip>76101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5262100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori IRCCS &quot;Fondazione G. Pascale&quot;</name>
      <address>
        <city>Napoli</city>
        <zip>52-80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Oncology and Radiology of Serbia</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quirónsalud Madrid</name>
      <address>
        <city>Pozuelo de Alarcón</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oncológico Dr. Rosell, Hospital Universitario Quirón Dexeus</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall D'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>START Madrid, Hospital Universitario Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Madrid Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Instituto Valenciano de Oncológia</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>May 17, 2021</last_update_submitted>
  <last_update_submitted_qc>May 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Circulating Tumor DNA</keyword>
  <keyword>HER2</keyword>
  <keyword>Genomic Screening</keyword>
  <keyword>Metastatic</keyword>
  <keyword>Breast</keyword>
  <keyword>Cervical</keyword>
  <keyword>ERBB2</keyword>
  <keyword>Mutation</keyword>
  <keyword>CDK4/6</keyword>
  <keyword>HR Positive</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.&#xD;
In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.&#xD;
Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.&#xD;
Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.</ipd_time_frame>
    <ipd_access_criteria>Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.&#xD;
Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.</ipd_access_criteria>
    <ipd_url>https://pumabiotechnology.com/data_sharing_policy.html</ipd_url>
  </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/NCT03786107
org study id: PUMA-NER-9501
nct id: NCT03786107
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This is a multi-center, observational genomic screening protocol to identify participants
      whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating
      tumor DNA (ctDNA) . Participants with histologically confirmed, hormone receptor positive,
      HER-2 negative, metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are
      eligible for screening at 6 months intervals, or if disease progression is
      suspected/confirmed. Blood samples will be collected from eligible participants and ctDNA
      will be extracted and sequenced at a central laboratory, using a HER2-targeted next
      generation sequencing (NGS) test. A certified molecular test report will be issued from the
      central laboratory and provided to the investigators and the study sponsor. Participants who
      are identified with HER2 mutations by this screening protocol will subsequently have access
      to an appropriate neratinib treatment protocol, pending medical eligibility.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants Eligible for Neratinib Treatment
time frame: From enrollment date to identification of HER2 positive mutation, assessed up to five years
description: Identification of participants with somatic, activating HER2 mutations who might qualify for enrollment into neratinib treatment protocols
intervention type: Diagnostic Test
intervention name: Almac HER-Seq Assay
description: whole blood sample analysis
Circulating tumor DNA from plasma will be collected from eligible participants. ERBB2 (HER2)
      gene exons 8 and 17-24 will be sequenced by next generation sequencing (NGS) at a central
      laboratory.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Senior Vice President Clinical Science and Pharmacology
role: Study Director
affiliation: Puma Biotechnology, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Ireland
country: Israel
country: Italy
country: Serbia
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
sharing ipd: Yes
ipd description: Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.
In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.
Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.
Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
ipd access criteria: Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.
Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
ipd url: https://pumabiotechnology.com/data_sharing_policy.html