Statements (56)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:legal_case
|
| gptkbp:advocates_for |
obtained from all participants
|
| gptkbp:analysis |
ongoing
conducted at specified intervals performed by biostatisticians |
| gptkbp:analyzes |
gptkb:pertuzumab
gptkb:trastuzumab |
| gptkbp:clinical_trial |
NC T01358877
defined prior to study initiation |
| gptkbp:collaborations |
gptkb:Genentech
involving multiple institutions |
| gptkbp:collection |
clinical assessments
|
| gptkbp:completed |
gptkb:2019
|
| gptkbp:criteria |
age 18 or older
previous anti-HE R2 therapy |
| gptkbp:events |
at least 5 years
|
| gptkbp:focuses_on |
HE R2-positive breast cancer
|
| gptkbp:followed_by |
planned for participants.
|
| https://www.w3.org/2000/01/rdf-schema#label |
APHINITY trial
|
| gptkbp:is_protected_by |
parallel assignment
|
| gptkbp:is_studied_in |
double-blind
|
| gptkbp:is_tested_for |
Phase III
|
| gptkbp:launch_date |
June 2011
|
| gptkbp:launched |
gptkb:2013
|
| gptkbp:location |
multiple countries
|
| gptkbp:moral |
obtained from ethics committees
|
| gptkbp:participants |
overall survival
disease-free survival |
| gptkbp:population |
women with early-stage breast cancer
|
| gptkbp:primary_source |
treatment
|
| gptkbp:products |
gptkb:pertuzumab
gptkb:trastuzumab |
| gptkbp:provides_information_on |
available upon request
|
| gptkbp:published_by |
gptkb:The_New_England_Journal_of_Medicine
|
| gptkbp:receives_funding_from |
provided by sponsors
|
| gptkbp:recorded_by |
1:1 ratio
|
| gptkbp:recruitment |
ongoing until target enrollment met
|
| gptkbp:regulatory_compliance |
FDA approved
EMA approved |
| gptkbp:research |
demonstrated efficacy
|
| gptkbp:result |
gptkb:2020
published in peer-reviewed journals showed improved outcomes |
| gptkbp:safety_features |
independent committee
|
| gptkbp:side_effect |
monitored
|
| gptkbp:sponsor |
gptkb:Roche
|
| gptkbp:student_enrollment |
HE R2-positive status required
approximately 4,800 patients |
| gptkbp:treatment |
trastuzumab plus pertuzumab vs trastuzumab alone
|
| gptkbp:type |
randomized trial
|
| gptkbp:updates |
January 2020
|
| gptkbp:vision |
participant and investigator
|
| gptkbp:year |
gptkb:2018
December 2019 |
| gptkbp:bfsParent |
gptkb:pertuzumab
|
| gptkbp:bfsLayer |
5
|