Adverse Event Clinical Research
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Adverse Event Clinical Research, 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-ig/ and changes regularly. See the Directory of published versions

ResearchStudy: Breast Cancer Trial

Page standards status: Informative

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)

studyDesign: Interventional research (Study Design#SEVCO:01001)

condition: Breast Cancer (SNOMED CT#254837009)

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.

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

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

associatedParty

name: Iam Recruitment Contact

role: recruitment-contact (Research Study Party Role#recruitment-contact)

classifier: Contact ()

party: : This would be a reference which would provide phone number

associatedParty

name: Alebund Pharmaceuticals

role: sponsor (Research Study Party Role#sponsor)

classifier: INDUSTRY ()

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

associatedParty

name: Alebund Pty Ltd

role: lead-sponsor (Research Study Party Role#lead-sponsor)

classifier: INDUSTRY ()

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

associatedParty

name: Sam Francis, Doctor

role: Principal Investigator (Research Study Party Role#primary-investigator "primary-investigator")

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

Recruitments

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

comparisonGroup

name: Arm A

type: Experimental (ResearchStudy Arm Type Code System#experimental)

description: Bresentrik (B) plus pertuzumab-matching placebo

comparisonGroup

name: Arm B

type: Experimental (ResearchStudy Arm Type Code System#experimental)

description: Bresentrik (B) plus pertuzumab

comparisonGroup

name: Arm C

type: Active Comparator (ResearchStudy Arm Type Code System#active-comparator)

description: Standard of care (Taxane (paclitaxel or docetaxel), trastuzumab, and pertuzumab)