<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>

Generated Narrative: ResearchStudy

Resource ResearchStudy "BreastCancerTrial"

identifier: http://clinicaltrials.gov//NCT01234567

title: Breast Cancer Clinical Trial bresentrik study

protocol: : This would reference the PlanDefinition which would contain references to Bresentrik

status: active

primaryPurposeType: Treatment (ResearchStudyPrimaryPurposeType#treatment)

phase: Phase 2/Phase 3 (ResearchStudyPhase#phase-2-phase-3)

category: Interventional research ()

condition: Breast Cancer (SNOMED CT#254837009)

contact: ph: 123-123-1234

description: 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: : This would be a reference to a Group, use Group.characteristic to define inclusion and exclusion criteria

period: 2021-03-23 --> 2029-03-23

sponsor: : This would be a reference Organization and would be the body legally responsible for the trial

principalInvestigator: : This would be a reference to a Practitioner or PractionerRole

site: : This would be a reference to a Location containing the facility where the trial is taking place

arm
name: Arm A
type: Experimental ()
description: Bresentrik (B) plus pertuzumab-matching placebo

arm
name: Arm B
type: Experimental ()
description: Bresentrik (B) plus pertuzumab

arm
name: Arm C
type: Active Comparator ()
description: Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)