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Welcome & Introduction
Sibylle HohlerGlobal Studies Leader
Professor Xavier PivotCHU Besancon, France
Welcome to the BEATRICE Investigator Meeting in Buenos Aires
Welcome to the study and site team members
Argentina Brazil Costa Rica
Mexico Peru
Independent Data
Monitoring Committee
Independent Data
Monitoring Committee
StatisticsCRO(IDDI)
StatisticsCRO(IDDI)
CTRU(University of Leeds)
Safety data
Efficacydata
Participating centres
Participating centres
CRO(Quintiles)
Clinical database
Safety data
Efficacydata
Medical SupportMedical Support
Independent Statistician
Independent Statistician
ROCHEROCHE
Event ReviewCommittee
Event ReviewCommittee
BEATRICE: Partnership between Academia and Roche
Trial Steering Group
Operational Partners
QuintilesResponsible for EC/IRB submissions and health authority submissions in selected countriesResponsible for site management (partial site selection, patient recruitment, site contracts, site monitoring)Responsible for all data management activities (database set up until database closure). Database held independently of Roche
Roche Country Study ManagersKeep relations to the sites to provide support on a local levelResponsible for co-monitoring
Roche Central TeamOverall cross-functional management i.e. Quintiles, CSMs, academic groupsMonitoring of study progress Ultimate decision making authority for operational aspects
BEATRICE Roche team members (Operations)
Mieke BorgsOperations Project
Leader
Christian AngstGlobal Studies Leader
Sibylle HohlerGlobal Studies Leader
Michaela WolfGlobal Study
Operations Manager
Shannon WhiteGlobal Study Operations
Manager
Birgit MazereelGlobal Studies Associate
BEATRICE Roche team members (Clinical Oncology, Statistics & Data Management)
Annabelle MonnetBio-Statistician
Louis ViviersClinical Scientist
Claire SenayClinical Science
Specialist
Patricia Gil-BazanClinical Science
Specialist
Anne RichouProject Data
Manager
Henry BennettStudy DataManager
Peter ChevertonClinical Science
Leader
Stefan SchererBiomarker Program Leader
Raj RallanGlobal Biosamples
Specialist
BEATRICE Roche team members (Biomarker)
BEATRICE Quintiles central team members
Jason JeffordProgramme Director
Farida Souami Project Manager Europe, Latin &
South America, South Africa
MurielCostantzer
EDC Manager
Sophie LambertData Management
Team Lead
Egle KamantauskaiteGlobal Clinical Team Lead
Welcome from the BEATRICE Trial Steering Group
Professor Xavier PivotCHU Besancon, France
BEATRICE Trial Steering Group (1)
David Cameron UK (Chair)
Richard BellAustralia
Rebecca DentCanada
John MackeyCanada
Christian JackischGermany
Xavier PivotFrance
BEATRICE Trial Steering Group (2)
Günther StegerAustria
Thomas Suter Switzerland
Louis ViviersRoche
Masakazu ToiJapan
Sibylle HohlerRoche
BEATRICE Translational Research Committee Chairs
Max ParmarUK
Annabelle MonnetRoche
Julia BrownUK
BEATRICE Trial Project Statisticians
Peter CarmelietBelgium
Stefan SchererRoche
Trial Steering Group (TSG) PartnershipTrial Steering Group
Richard Bell Australia David Cameron UKRebecca Dent Canada Christian Jackisch GermanyJohn Mackey CanadaXavier Pivot FranceGünther Steger AustriaThomas Suter SwitzerlandMasakazu Toi Japan
Julia Brown Independent Statistician/Head of Leeds CTRU
Max Parmar Independent Statistician, MRC
Sibylle Hohler Roche OperationsAnnabelle Monnet Roche StatisticsLouis Viviers Roche Clinical Science
Translational Research CommitteePeter Carmeliet BelgiumAndy Tutt UK
Stefan Scherer Roche BiomarkerProgram Leader
Louis Viviers Roche Clinical Science
Objectives
What is BEATRICE ?
Why treat breast cancer with an anti-angiogenic?
Why select ‘Triple Negative’ Breast Cancers?
What is the basic trial design?
How do we run a trial in an Academic-Pharma partnership?
ER/PR/HER2 -ER/PR/HER2 -
“basal-like”
The “Triple Negative” Breast Cancer
Estrogen Receptor (ER) negativeProgesterone receptor (PR) negative
Her2neu (HER2) negative
Arm A
Surgery
Randomisation with StratificationNodal status
ChemotherapyHormone receptors
Type of surgery
Central confirmation of HR & HER2 status
Chemotherapy
Arm B
Chemotherapy Bevacizumab
Early breast cancer“Triple negative” and/or Basal-like subtype
Efficacy and Safety Follow-up (year 2-7)
Trial End Points
Surveillance Bevacizumab
(Year 1)
BEATRICE
The clinical need“Triple negative” tumours associated with poor outcome
The opportunityAngiogenesis as a target
The targeted agentBevacizumab
The Partnership
AcademiaConceptPatients
RocheDrugInfrastructure
Leeds CTRUGovernance
BEATRICE Partnership → Protects the interests of women
Role of AcademiaAnalyses free from commercial concernsInterest in long-term outcome dataReflect clinical practice, not just regulatory view
Role of PharmaSafety reporting and monitoringHigh quality data management systemsFully-funded studyEstablished bio-repository
SAEs Narratives
Independent Data
Monitoring Committee
Independent Data
Monitoring Committee
StatisticsCRO(IDDI)
StatisticsCRO(IDDI)
CTRU(University of Leeds)
Safety data
Efficacydata
Participating centres
Participating centres
CRO(Quintiles)
Clinical database
Safety data
Efficacydata
Medical SupportMedical Support
Independent Statistician
Independent Statistician
ROCHEROCHE
Event ReviewCommittee
Event ReviewCommittee
Independent Data Monitoring Committee and its interaction with other involved parties
Trial Steering Group
Translational analyses
Samples only taken with explicit consent
Tumour samples taken at time of central eligibility review
All analyses conducted with agreement of Translational Research sub-committee
Can be done in Roche, academic lab or other labAll links to clinical data overseen by Independent statistician
All publications have to be approved by Trial Steering Group
Data ownership
All clinical and biological data
Owned by Roche
Access granted by IDMC
Controlled by Translational Subcommittee of TSG for publication and presentation
Controlled by Roche for Registration
Participating Countries at this Meeting: Site distribution
20 Sites, 130 patients• Argentina• Brazil• Mexico• Costa Rica• Peru
Countries involved
CanadaUSA Australia
ChinaHong Kong
JapanKorea
MalaysiaNew ZealandPhilippinesSingapore
TaiwanThailand
S Africa
ArgentinaBrazil
MexicoCosta Rica
Peru
AustriaBelgiumBosnia
Czech RepFinlandFrance
GermanyGreeceIsraelItaly
Macedonia
NetherlandsPoland
PortugalRomaniaRussiaSerbiaSpain
SwedenSwitzerland
UK
Timelines
N = 2530
First Patient Enrolled: Dec 2007
Last Patient Enrolled: Dec 2009
Efficacy analysis: After 388 primary endpoint events have been observed
End of study after 340 deaths have occurred
Agenda Day 1 AM – Thursday 24 April
10h15 Avastin® Development Plan Christian Angst
10h35 Anti-angiogenesis in Breast Cancer Peter Cheverton
10h55 Triple-negative Breast Cancer Dr Rebecca Dent
11h20 Coffee Break
11h50 Clinical Review of the BEATRICE Protocol: Part 1 Louis Viviers
12h40 Biomarker and Translational Medicine in BEATRICE Stefan Scherer
13h05 Q & A Panel & Audience
13h20 Lunch
Agenda Day 1 PM - Thursday 24 April
14h20 Clinical Review of the BEATRICE Protocol: Part 2 Louis Viviers
16h00 Q& A Session Panel & Audience
16h30 Coffee Break
17h00 ICH GCP Quiz Farida Souami
17h25Data Management for the BEATRICEStudy
Henry Bennett &Sophie Lambert
17h55 Wrap up Day 1
Agenda Day 2 – Friday 25 April 08h30 Review of Day 1 Sibylle Hohler
08h45Operations
Central testingManagement of study drug
Michaela Wolf
09h10 SDE Process Farida Souami
09h55 IVRS: A practical review Jason Jefford10h15 Coffee
10h45 eCRF completion: A practical review Henry Bennett & Sophie Lambert
12h00 SAE Reporting Egle Kamantauskaite12h25 Patient recruitment & Patient retention Jason Jefford12h40 Review of Day 1 & 2 (group quiz) Sibylle Hohler13h00 Meeting finish
09h25 BSR & RSR: A practical review Raj Rallan
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