Adverse Event Clinical Research R4 Backport
1.0.1 - STU1 International flag

Adverse Event Clinical Research R4 Backport, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-backport-ig/ and changes regularly. See the Directory of published versions

ResearchStudy: Breast Cancer Trial

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)