Adverse Event Clinical Research R4 Backport
1.0.1 - STU1 International flag

This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

: Breast Cancer Trial - XML Representation

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<ResearchStudy xmlns="http://hl7.org/fhir">
  <id value="BreastCancerTrial"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ResearchStudy</b><a name="BreastCancerTrial"> </a><a name="hcBreastCancerTrial"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ResearchStudy &quot;BreastCancerTrial&quot; </p></div><p><b>identifier</b>: <code>http://clinicaltrials.gov/</code>/NCT01234567</p><p><b>title</b>: Breast Cancer Clinical Trial bresentrik study</p><p><b>protocol</b>: <span>: This would reference the PlanDefinition which would contain references to Bresentrik</span></p><p><b>status</b>: active</p><p><b>primaryPurposeType</b>: Treatment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-research-study-prim-purp-type.html">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 2/Phase 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-research-study-phase.html">ResearchStudyPhase</a>#phase-2-phase-3)</span></p><p><b>category</b>: Interventional research <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>condition</b>: Breast Cancer <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#254837009)</span></p><p><b>contact</b>: ph: 123-123-1234</p><p><b>description</b>: Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer. The study aims to evaluate the efficacy, and safety of bresentrik, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if bresentrik allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.</p><p><b>enrollment</b>: <span>: This would be a reference to a Group, use Group.characteristic to define inclusion and exclusion criteria</span></p><p><b>period</b>: 2021-03-23 --&gt; 2029-03-23</p><p><b>sponsor</b>: <span>: This would be a reference Organization and would be the body legally responsible for the trial</span></p><p><b>principalInvestigator</b>: <span>: This would be a reference to a Practitioner or PractionerRole</span></p><p><b>site</b>: <span>: This would be a reference to a Location containing the facility where the trial is taking place</span></p><blockquote><p><b>arm</b></p><p><b>name</b>: Arm A</p><p><b>type</b>: Experimental <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>description</b>: Bresentrik (B) plus pertuzumab-matching placebo</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Arm B</p><p><b>type</b>: Experimental <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>description</b>: Bresentrik (B) plus pertuzumab</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Arm C</p><p><b>type</b>: Active Comparator <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>description</b>: Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)</p></blockquote></div>
  </text>
  <identifier>
    <system value="http://clinicaltrials.gov/"/>
    <value value="NCT01234567"/>
    <assigner>
      <display value="Allesgut Pharmaceuticals"/>
    </assigner>
  </identifier>
  <title value="Breast Cancer Clinical Trial bresentrik study"/>
  <protocol>
    <display
             value="This would reference the PlanDefinition which would contain references to Bresentrik"/>
  </protocol>
  <status value="active"/>
  <primaryPurposeType>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"/>
      <code value="treatment"/>
      <display value="Treatment"/>
    </coding>
  </primaryPurposeType>
  <phase>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <code value="phase-2-phase-3"/>
    </coding>
  </phase>
  <category>
    <text value="Interventional research"/>
  </category>
  <condition>
    <coding>
      <system value="http://snomed.info/sct"/>
      <code value="254837009"/>
      <display value="Breast Cancer"/>
    </coding>
  </condition>
  <contact>
    <telecom>
      <system value="phone"/>
      <value value="123-123-1234"/>
    </telecom>
  </contact>
  <description
               value="Eligible participants will be those diagnosed with HER2-positive (IHC 3+ or ISH+), metastatic breast cancer, who have received no prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer. The study aims to evaluate the efficacy, and safety of bresentrik, alone or with pertuzumab, compared with the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). This study aims to see if bresentrik allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life."/>
  <enrollment>
    <display
             value="This would be a reference to a Group, use Group.characteristic to define inclusion and exclusion criteria"/>
  </enrollment>
  <period>
    <start value="2021-03-23"/>
    <end value="2029-03-23"/>
  </period>
  <sponsor>
    <display
             value="This would be a reference Organization and would be the body legally responsible for the trial"/>
  </sponsor>
  <principalInvestigator>
    <display
             value="This would be a reference to a Practitioner or PractionerRole"/>
  </principalInvestigator>
  <site>
    <display
             value="This would be a reference to a Location containing the facility where the trial is taking place"/>
  </site>
  <arm>
    <name value="Arm A"/>
    <type>
      <text value="Experimental"/>
    </type>
    <description value="Bresentrik (B) plus pertuzumab-matching placebo"/>
  </arm>
  <arm>
    <name value="Arm B"/>
    <type>
      <text value="Experimental"/>
    </type>
    <description value="Bresentrik (B) plus pertuzumab"/>
  </arm>
  <arm>
    <name value="Arm C"/>
    <type>
      <text value="Active Comparator"/>
    </type>
    <description
                 value="Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)"/>
  </arm>
</ResearchStudy>