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/NCT05993234</url>
    </required_header>
    <id_info>
      <org_study_id>DS8201-0007-NIS-MA</org_study_id>
      <nct_id>NCT05993234</nct_id>
    </id_info>
    <brief_title>A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies (PROSPERITY)</brief_title>
    <official_title>A Prospective Non-interventional Study (NIS) of Trastuzumab DeRuxtecan (T-DXd) for Adult Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction (GEJ) AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen, Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies in a Real-world Setting in Europe (PROSPERITY)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Daiichi Sankyo, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Trastuzumab deruxtecan (T-DXD) as monotherapy is indicated for the treatment of adult&#xD;
        patients with advanced HER2-positive advanced gastric or gastroesophageal junction (GEJ)&#xD;
        adenocarcinoma who have received a prior trastuzumab-based regimen.&#xD;
  &#xD;
        This study will assess the effectiveness of T-DXd, patient demographic and clinical&#xD;
        characteristics, and treatment patterns in patients with advanced HER2-positive advanced&#xD;
        gastric or GEJ adenocarcinoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This non-interventional study will investigate the effectiveness of T-DXd, the patients&#xD;
        demographic and clinical characteristics, treatment patterns including prophylactic&#xD;
        medications and interventions for reduction of serious adverse events (SAEs), serious adverse&#xD;
        drug reactions (ADRs) and safety event of interest (SEIs), tolerability, and patient survey&#xD;
        of T-DXd, in cases with advanced HER2-positive gastric or GEJ adenocarcinoma receiving T-DXd&#xD;
        as second line of treatment and beyond treatment option. Patients will be treated according&#xD;
        to the proposed indication statement in the Summary of Product Characteristics (SmPC). No&#xD;
        investigational drug will be administered in this study.&#xD;
  &#xD;
        Data on conventional therapy (including platinum-fluoropyrimidine doublet chemotherapy,&#xD;
        nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and&#xD;
        pembrolizumab monotherapy) will also be collected in a disease registry part of the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>2 Years</target_duration>
    <primary_outcome>
      <measure>Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma</measure>
      <time_frame>Baseline up to approximately 2 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Physician Visits and Treatment Changes in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma</measure>
      <time_frame>Baseline up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only)</measure>
      <time_frame>Baseline up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only)</measure>
      <time_frame>Baseline up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Real-World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma</measure>
      <time_frame>Baseline up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma</measure>
      <time_frame>Baseline up to approximately 2 years</time_frame>
      <description>The EORTC QLQ-C30 questionnaire is a cancer-specific quality of life instrument applicable to a broad range of cancer patients. The EORTC QLQ-C30 scales and single-item scales range in score from 0 to 100. A higher score for the functioning scales and global health status denotes a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Stomach (EORTC QLQ-STO22) Score in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma</measure>
      <time_frame>Baseline up to approximately 2 years</time_frame>
      <description>The EORTC QLQ-STO22 is a gastric cancer-specific module which has been developed to measure the quality of life in patients with gastric cancer. The gastric cancer specific questions on the EORTC QLQ-STO22 include four single-item subscales (dry mouth, body image, hair loss and problems with taste) and five multi-item subscales (dysphagia, dietary restriction, pain, upper gastroesophageal symptoms and emotional problems). The EORTC QLQ single-item and multi-item scales range in score from 0 to 100. A higher score on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient)</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">368</enrollment>
    <condition>HER2-positive Advanced Gastric Cancer</condition>
    <condition>HER2-positive Gastroesophageal Junction Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>Trastuzumab deruxtecan (T-DXd)</arm_group_label>
      <description>Participants with HER2-positive gastric or gastroesophageal junction adenocarcinoma who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional therapy. The participants on conventional therapy will be analyzed for exploratory purposes only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Trastuzumab deruxtecan</intervention_name>
      <description>This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice.&#xD;
  T-DXd to be administered according to the SmPC. Conventional therapy (eg. platinum-fluoropyrimidine doublet chemotherapy, nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and pembrolizumab monotherapy) to be administered according to the SmPC.</description>
      <arm_group_label>Trastuzumab deruxtecan (T-DXd)</arm_group_label>
      <other_name>T-DXd</other_name>
      <other_name>ENHERTU®</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients with advanced HER2-positive gastric or GEJ adenocarcinoma who have received&#xD;
          a prior trastuzumab-based regimen in a real-world setting in Europe.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female adult patient (age ≥ 18 years) with HER2 + advanced gastric or GEJ&#xD;
               adenocarcinoma who have received a prior trastuzumab based regimen&#xD;
  &#xD;
            -  Histological or cytological confirmed diagnosis of advanced HER2 positive gastric&#xD;
               cancer or GEJ&#xD;
  &#xD;
            -  Documented HER2 + status (archival sample or recent sample prior 2L therapy)&#xD;
  &#xD;
            -  Decision to newly initiate monotherapy T-DXd or conventional therapies per SMPC&#xD;
               according to the physician's choice&#xD;
  &#xD;
            -  Written dated and signed Informed Consent (ICF) to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who at time of data collection for this study are participating in or have&#xD;
               participated in an interventional study that remains blinded&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
          No specific exclusion criteria are defined, as patients will be treated according to the&#xD;
          proposed indication statements in the SmPC.&#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>Global Team Leader</last_name>
      <role>Study Director</role>
      <affiliation>Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Contact for Clinical Trial Information</last_name>
      <phone>908-992-6400</phone>
      <email>CTRinfo@dsi.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HER2-positive Advanced Gastric Cancer</keyword>
    <keyword>HER2-positive Gastroesophageal Junction Adenocarcinoma</keyword>
    <keyword>Trastuzumab Deruxtecan</keyword>
    <keyword>Conventional therapy</keyword>
    <keyword>ENHERTU®</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenocarcinoma</mesh_term>
      <mesh_term>Stomach Neoplasms</mesh_term>
      <mesh_term>Esophageal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Trastuzumab</mesh_term>
      <mesh_term>Trastuzumab deruxtecan</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/NCT05993234
  org study id: DS8201-0007-NIS-MA
  nct id: NCT05993234
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  Trastuzumab deruxtecan (T-DXD) as monotherapy is indicated for the treatment of adult
        patients with advanced HER2-positive advanced gastric or gastroesophageal junction (GEJ)
        adenocarcinoma who have received a prior trastuzumab-based regimen.
  
        This study will assess the effectiveness of T-DXd, patient demographic and clinical
        characteristics, and treatment patterns in patients with advanced HER2-positive advanced
        gastric or GEJ adenocarcinoma.
  This non-interventional study will investigate the effectiveness of T-DXd, the patients
        demographic and clinical characteristics, treatment patterns including prophylactic
        medications and interventions for reduction of serious adverse events (SAEs), serious adverse
        drug reactions (ADRs) and safety event of interest (SEIs), tolerability, and patient survey
        of T-DXd, in cases with advanced HER2-positive gastric or GEJ adenocarcinoma receiving T-DXd
        as second line of treatment and beyond treatment option. Patients will be treated according
        to the proposed indication statement in the Summary of Product Characteristics (SmPC). No
        investigational drug will be administered in this study.
  
        Data on conventional therapy (including platinum-fluoropyrimidine doublet chemotherapy,
        nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and
        pembrolizumab monotherapy) will also be collected in a disease registry part of the study.
  observational model: Cohort
  time perspective: Prospective
  measure: Real-World Time to Next Treatment (rwTTNT1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
  time frame: Baseline up to approximately 2 years
  measure: Number of Physician Visits and Treatment Changes in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
  time frame: Baseline up to approximately 2 years
  measure: Number of Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only)
  time frame: Baseline up to approximately 2 years
  measure: Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (T-DXd only)
  time frame: Baseline up to approximately 2 years
  measure: Real-World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
  time frame: Baseline up to approximately 2 years
  measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
  time frame: Baseline up to approximately 2 years
  description: The EORTC QLQ-C30 questionnaire is a cancer-specific quality of life instrument applicable to a broad range of cancer patients. The EORTC QLQ-C30 scales and single-item scales range in score from 0 to 100. A higher score for the functioning scales and global health status denotes a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
  measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Stomach (EORTC QLQ-STO22) Score in Participants With HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
  time frame: Baseline up to approximately 2 years
  description: The EORTC QLQ-STO22 is a gastric cancer-specific module which has been developed to measure the quality of life in patients with gastric cancer. The gastric cancer specific questions on the EORTC QLQ-STO22 include four single-item subscales (dry mouth, body image, hair loss and problems with taste) and five multi-item subscales (dysphagia, dietary restriction, pain, upper gastroesophageal symptoms and emotional problems). The EORTC QLQ single-item and multi-item scales range in score from 0 to 100. A higher score on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient)
  arm group label: Trastuzumab deruxtecan (T-DXd)
  description: Participants with HER2-positive gastric or gastroesophageal junction adenocarcinoma who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional therapy. The participants on conventional therapy will be analyzed for exploratory purposes only.
  intervention type: Drug
  intervention name: Trastuzumab deruxtecan
  description: This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice.
  T-DXd to be administered according to the SmPC. Conventional therapy (eg. platinum-fluoropyrimidine doublet chemotherapy, nivolumab, ramucirumab-paclitaxel, ramucirumab monotherapy, taxane or irinotecan, and pembrolizumab monotherapy) to be administered according to the SmPC.
  arm group label: Trastuzumab deruxtecan (T-DXd)
  other name: T-DXd
  other name: ENHERTU®
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Global Team Leader
  role: Study Director
  affiliation: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
  last name: Contact for Clinical Trial Information
  phone: 908-992-6400
  email: CTRinfo@dsi.com
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  mesh term: Stomach Neoplasms
  mesh term: Esophageal Neoplasms
  mesh term: Trastuzumab
  mesh term: Trastuzumab deruxtecan
  sharing ipd: No