|
gptkbp:instance_of
|
gptkb:Clinical_Trials
|
|
gptkbp:advocacy
|
informed consent obtained
|
|
gptkbp:analysis
|
survival analysis
|
|
gptkbp:blinded
|
no
|
|
gptkbp:business_model
|
obtained from IRB
|
|
gptkbp:clinical_trial
|
PALOMA-1, PALOMA-2
NCT01942135
|
|
gptkbp:collaborator
|
gptkb:Breast_International_Group
gptkb:SWOG_Cancer_Research_Network
gptkb:National_Institutes_of_Health
gptkb:European_Society_for_Medical_Oncology
gptkb:American_Society_of_Clinical_Oncology
various cancer research organizations
Alliance Foundation Trials
|
|
gptkbp:collection
|
clinical assessments
|
|
gptkbp:completed
|
gptkb:2016
|
|
gptkbp:criteria
|
gptkb:ER+/_HER2-breast_cancer
gptkb:hormone_receptor-positive_breast_cancer
prior chemotherapy
prior chemotherapy for advanced disease
|
|
gptkbp:drug_administered
|
gptkb:palbociclib
gptkb:letrozole
|
|
gptkbp:drug_combination
|
letrozole and palbociclib
|
|
gptkbp:duration
|
up to 24 cycles
|
|
gptkbp:eligibility
|
gptkb:hormone_receptor-positive_breast_cancer
|
|
gptkbp:end_date
|
gptkb:2016
April 2016
|
|
gptkbp:events
|
24 months
|
|
gptkbp:field_of_study
|
oncology
|
|
gptkbp:focuses_on
|
gptkb:palbociclib
gptkb:hormone_receptor-positive_breast_cancer
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
PALOMA-3 Trial
|
|
gptkbp:investigates
|
gptkb:Dr._Richard_S._Finn
gptkb:palbociclib
gptkb:Oncology
|
|
gptkbp:is_compared_to
|
palbociclib plus letrozole vs letrozole alone
|
|
gptkbp:is_located_in
|
gptkb:United_States
|
|
gptkbp:is_studied_in
|
multicenter study
multicenter, randomized, double-blind
|
|
gptkbp:is_tested_for
|
Phase 2
Phase 3
|
|
gptkbp:location
|
multiple countries
multiple sites
|
|
gptkbp:members
|
placebo
|
|
gptkbp:notable_work
|
combination therapy effective
palbociclib improves outcomes
|
|
gptkbp:participants
|
gptkb:women
overall survival
progression-free survival
tumor response rate
|
|
gptkbp:patient_population
|
postmenopausal women
|
|
gptkbp:prevention
|
parallel assignment
|
|
gptkbp:primary_use
|
treatment
|
|
gptkbp:provides_guidance_on
|
influenced treatment guidelines
|
|
gptkbp:provides_information_on
|
available upon request
|
|
gptkbp:publication
|
gptkb:The_New_England_Journal_of_Medicine
|
|
gptkbp:publication_year
|
gptkb:2016
|
|
gptkbp:regulatory_compliance
|
FDA approved
|
|
gptkbp:research
|
interventional
|
|
gptkbp:result
|
gptkb:2018
gptkb:The_New_England_Journal_of_Medicine
improved progression-free survival
significant improvement in PFS
|
|
gptkbp:sampled_in
|
yes
666 patients
|
|
gptkbp:side_effect
|
fatigue
nausea
diarrhea
neutropenia
|
|
gptkbp:sponsored_by
|
gptkb:Pfizer
|
|
gptkbp:start_date
|
gptkb:2014
October 2014
|
|
gptkbp:started_in
|
gptkb:2014
|
|
gptkbp:status
|
completed
|
|
gptkbp:student_enrollment
|
666 participants
|
|
gptkbp:study_status
|
completed
|
|
gptkbp:target_audience
|
postmenopausal women
|
|
gptkbp:treatment
|
combination therapy
hormonal therapy
|
|
gptkbp:vision
|
double-blind
|
|
gptkbp:year
|
gptkb:2015
|