Adverse Event Clinical Research R4 Backport
1.0.0-ballot - ballot International flag

This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

: Breast Cancer Trial - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix sct: <http://snomed.info/id/> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:ResearchStudy ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "BreastCancerTrial"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"BreastCancerTrial\"> </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>: id: 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/5.0.0/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/5.0.0/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>"
  ] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "http://clinicaltrials.gov/"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT01234567" ] ;
fhir:assigner [
fhir:display [ fhir:v "Allesgut Pharmaceuticals" ]     ]
  ] ) ; # 
  fhir:title [ fhir:v "Breast Cancer Clinical Trial bresentrik study"] ; # 
  fhir:protocol ( [
fhir:display [ fhir:v "This would reference the PlanDefinition which would contain references to Bresentrik" ]
  ] ) ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:primaryPurposeType [
    ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "treatment" ] ;
fhir:display [ fhir:v "Treatment" ]     ] )
  ] ; # 
  fhir:phase [
    ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-phase"^^xsd:anyURI ] ;
fhir:code [ fhir:v "phase-2-phase-3" ]     ] )
  ] ; # 
  fhir:category ( [
fhir:text [ fhir:v "Interventional research" ]
  ] ) ; # 
  fhir:condition ( [
    ( fhir:coding [
a sct:254837009 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "254837009" ] ;
fhir:display [ fhir:v "Breast Cancer" ]     ] )
  ] ) ; # 
  fhir:contact ( [
    ( fhir:telecom [
fhir:system [ fhir:v "phone" ] ;
fhir:value [ fhir:v "123-123-1234" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "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."] ; # 
  fhir:enrollment ( [
fhir:display [ fhir:v "This would be a reference to a Group, use Group.characteristic to define inclusion and exclusion criteria" ]
  ] ) ; # 
  fhir:period [
fhir:start [ fhir:v "2021-03-23"^^xsd:date ] ;
fhir:end [ fhir:v "2029-03-23"^^xsd:date ]
  ] ; # 
  fhir:sponsor [
fhir:display [ fhir:v "This would be a reference Organization and would be the body legally responsible for the trial" ]
  ] ; # 
  fhir:principalInvestigator [
fhir:display [ fhir:v "This would be a reference to a Practitioner or PractionerRole" ]
  ] ; # 
  fhir:site ( [
fhir:display [ fhir:v "This would be a reference to a Location containing the facility where the trial is taking place" ]
  ] ) ; # 
  fhir:arm ( [
fhir:name [ fhir:v "Arm A" ] ;
fhir:type [
fhir:text [ fhir:v "Experimental" ]     ] ;
fhir:description [ fhir:v "Bresentrik (B) plus pertuzumab-matching placebo" ]
  ] [
fhir:name [ fhir:v "Arm B" ] ;
fhir:type [
fhir:text [ fhir:v "Experimental" ]     ] ;
fhir:description [ fhir:v "Bresentrik (B) plus pertuzumab" ]
  ] [
fhir:name [ fhir:v "Arm C" ] ;
fhir:type [
fhir:text [ fhir:v "Active Comparator" ]     ] ;
fhir:description [ fhir:v "Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)" ]
  ] ) . #