Unicancer-Innovation Through Cooperation - Thomas Bachelot, Président UCBG
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Unicancer-Innovation Through Cooperation
Thomas Bachelot, Président UCBG
Plan
History
From « Copil Pacs » to UCBG, alliance with GINECO
Actual Organization, numbers
Main strategies and recent achievement
Research interest
International collaboration
Focus on recent realization
Perspectives
Research program
Collaboration
February 2020— R&D UNICANCER 2
Plan
History
From « Copil Pacs » to UCBG, alliance with GINECO
Actual Organization, numbers
Main strategies and recent achievement
Research interest
International collaboration
Focus on recent realization
Perspectives
Research program
Collaboration
February 2020— R&D UNICANCER 3
History
Clinical research organization in France before 1990
February 2020— R&D UNICANCER 4
History
Until 1990, there was no official national cooperative group for
breast cancer research in France
In 1994, the French federation of comprehensive cancer center
decided to create a coordinating structure
=> CCMI: Commissions de Coopération Médicale Intercentre
=> Programmes d’actions concertées (PACS)
Adjuvant taxan and trastuzumab
February 2020— R&D UNICANCER 5
Historic
Until 1990, there was no official national cooperative group for
breast cancer research in France
In 1994, the French federation of comprehensive cancer center
decided to create a coordinating structure
=> CCMI: Commissions de Coopération Médicale Intercentre
=> Programmes d’actions concertées (PACS)
Adjuvant taxan and trastuzumab
February 2020— R&D UNICANCER 6
Historic
Until 1990, there was no official national cooperative group for
breast cancer research in France
In 1994, the French federation of comprehensive cancer center
decided to create a coordinating structure
=> CCMI: Commissions de Coopération Médicale Intercentre
=> Programmes d’actions concertées (PACS)
Adjuvant taxan and trastuzumab
February 2020— R&D UNICANCER 7
Historic
Until 1990, there was no official national cooperative group for
breast cancer research in France
In 1994, the French federation of comprehensive cancer center
decided to create a coordinating structure
=> CCMI: Commissions de Coopération Médicale Intercentre
=> Programmes d’actions concertées (PACS)
Adjuvant taxan and trastuzumab
February 2020— R&D UNICANCER 8
Historic
Until 1990, there was no official national cooperative group for
breast cancer research in France
In 1994, the French federation of comprehensive cancer center
decided to create a coordinating structure
=> CCMI: Commissions de Coopération Médicale Intercentre
=> Programmes d’actions concertées (PACS)
Adjuvant taxan and trastuzumab
=> Join the BIG for MINDACT in 2005
February 2020— R&D UNICANCER 9
History
Too much franco-french
Highly
Hardactive when
to move motivated
forward with big! studies
Adjuvant taxan and trastuzumab
7038
=> Join the BIG for MINDACT in 2005
February 2020— R&D UNICANCER 11History
2010: UNICANCER R&D -> Unicancer Breast Group
(UCBG) -> Président H Bonnefoi
New leader : Fabrice André, Suzette Delaloge, Mario Campone, JeanYves
Pierga, Thomas Bachelot, Etienne Brain
Association with the GINECO group (for Breast cancer research)
Accreditation from the French National Cancer Institute (INCA)
February 2020— R&D UNICANCER 12History
2010: UNICANCER R&D -> Unicancer Breast Group
(UCBG) -> Président H Bonnefoi
2015. President : Suzette Delaloge
2019. President : Thomas Bachelot
30 Members Scientific committee (CS3), including representative from
GINECO, Cancer Centers, University Hospital (Belgian included), Public
Hospital, Private practice, Patients.
10 members restricted board (Suzette Delaloge, Fabice André, Hervé
Bonnefoi, Jean-Yves Pierga, Anne-Claire Hardy, Paul Cottu, Anthony
Gonçalves, Frédérique Penault Llorca, Jérome Lemonnier)
February 2020— R&D UNICANCER 13A large base of investigator
February 2020— R&D UNICANCER 14Inclusion by years and open studies
Hospital category
1%
8%
12%
CLCC
CHU
Privés
AP-HP
79%
February 2020— R&D UNICANCER 15Inclusion by years and open studies
Hospital category Hospital category GINECO 2019
1% Hospital\Pub
8% lic hospital
23,29%
12%
CLCC
CHU
Privés
AP-HP Hospital\Anti
79% Hospital\Priv -cancer
ate hospital center
20,62% 56,09%
February 2020— R&D UNICANCER 16Plan
Historic
From « Copil Pacs » to UCBG, alliance with GINECO
Actual Organization, numbers
Main strategies and recent achievement
Research interest
International collaboration
Focus on recent realization
Perspectives
Research program
Collaboration
February 2020— R&D UNICANCER 17Main strategies and recent achievement
2015 : Strategy defined by the Scientific committee (CS3)
1. Biomarker-based precision medicine and immune therapy
in adjuvant and advanced settings
• Including Development of circulating precision oncology
2. Survivorship and long term safety
3. Elderly program (collab. Gerico)
4. Precision prevention
February 2020— R&D UNICANCER 18Recent and Current studies
Setting
Prevention Early BC Advanced disease
Impassion 030
BIG/Roche PALATINE DOLAF
MyPeBS
ROMANCE
European
TracerX START
Grant
HypoG01 PATINA
Ultimate Alliance
UCBG/BIG
UNIRAD
(UCBG/UK)
PENELOPE PADA1
(1050 pts)
GBG/BIG OLYMPIA
(121/1250) BIG/AZ
(142/1824)
CANTO SAFIR2
ASTER70 (12 000 pts)
LIBER (1989 pts) RxPonder (1460 pts)
SWOG
1022/5000
TRIAL MATURATION
Accural February 2020— R&D UNICANCER 20
Follow-upRecent and Current studies
Setting
Prevention Early BC Advanced disease
Impassion 030
BIG/Roche PALATINE DOLAF
MyPeBS
ROMANCE
European
TracerX START
Grant
HypoG01 PATINA
Ultimate Alliance
UCBG/BIG
UNIRAD
(UCBG/UK)
PENELOPE PADA1
(1050 pts)
GBG/BIG OLYMPIA
(121/1250) BIG/AZ
(142/1824)
CANTO SAFIR2
ASTER70 (12 000 pts)
LIBER (1989 pts) RxPonder (1460 pts)
SWOG
1022/5000
TRIAL MATURATION
Accural February 2020— R&D UNICANCER 21
Follow-upBiomarker-based precision medicine
2011-2012 : SAFIR1
=> CGH array and DNA sequencing to direct treatment of metastatic breast cancer
=> 423 patients enrolled, 299 genomic analysis, 195 targetable genomic alterations,
55 patients received matched therapy
February 2020— R&D UNICANCER 22
André et al. Lancet Oncol 2014; 15: 267–74Biomarker-based precision medicine
2011-2012 : SAFIR1
=> CGH array and DNA sequencing to direct treatment of metastatic breast cancer
=> 423 patients enrolled, 299 genomic analysis, 195 targetable genomic alterations,
55 patients received matched therapy
February 2020— R&D UNICANCER 23
André et al. Lancet Oncol 2014; 15: 267–74Biomarker-based precision medicine
2014-2020 : SAFIR2
February 2020— R&D UNICANCER 29Biomarker-based precision medicine
2014-2020 : SAFIR2
February 2020— R&D UNICANCER 30Biomarker-based precision medicine
2014-2020 : SAFIR2
February 2020— R&D UNICANCER 31
F Dalenc et al. SABCS 2019Biomarker-based precision medicine
2014-2020 : SAFIR2
February 2020— R&D UNICANCER 33
F Dalenc et al. SABCS 2019Biomarker-based precision medicine
2014-2020 : SAFIR2
February 2020— R&D UNICANCER 34
F Dalenc et al. SABCS 2019Biomarker-based precision medicine
2014-2020 : SAFIR2
February 2020— R&D UNICANCER 35
F Dalenc et al. SABCS 2019Biomarker-based precision medicine
2017-2020 : PADA1 : Science + Access program
P.I. : Francois-Clement BIDARD
February 2020— R&D UNICANCER 36Biomarker-based precision medicine
2017-2020 : PADA1 : Science + Access program
P.I. : Francois-Clement BIDARD
February 2020— R&D UNICANCER 37Elderly program (collaboration with Gerico). ASTER 70 / GERICO11
P.I. : Etienne Brain
February 2020— R&D UNICANCER 39Elderly program (collaboration with Gerico). ASTER 70 / GERICO11
Final analysis at 4 year follow up (April 2020)
P.I. : Etienne Brain
February 2020— R&D UNICANCER 40Adjuvant high risk : UNIRAD study (collaboration UK : David Cameron)
Everolimus in the adjuvant setting (PI T Bachelot & F André)
Breast cancer
RE+/HER2- > 3N+
Or HT and 2 years placebo
≥ 1N+ after
neo adjuvant
Or R
1-3 N+ Genomic High risk
(endopredict) HT
+ 2 years everolimus 10 mg/d
Any time from 1 to 4 years (start 5mg)
post surgery
February 2020— R&D UNICANCER 41Adjuvant high risk : UNIRAD study (collaboration UK : David Cameron)
Everolimus in the adjuvant setting (PI T Bachelot & F André)
Breast cancer HT and 2 years placebo
RE+/HER2-
4N+ or
≥ 1n+ after
neo adjuvant R
Treatment
Or HT
Genomic High risk + 2 years everolimus 10 mg/d
(endopredict) (start 5mg)
Any time from 1 to 4 years
post surgery
First interim analysis ongoing
February 2020— R&D UNICANCER 42Survivorship and long term safety : CANcer Toxicities (CANTO)
CANTO (CANcer TOxicities; NCT01993498)
• prospective longitudinal cohort started in 2012 (Ines Vaz-Luis & F André)
• 26 French comprehensive cancer centers
Primary Objectives
Identify factors predictive of long term breast cancer treatment-related toxicities
Secondary Objectives
Describe long term toxicities incidence/prevalence and psychological, social and economic, functional impact
Build a French prospective database of long term toxicities among breast cancer survivors and a multi-
disciplinary network that will leveraged on the dataset findings
Inclusion criteria
• 18+ years old at breast cancer diagnosis
• Histologically confirmed invasive breast cancer
• Stage I-II-III
• Untreated at time of inclusion (including primary surgery)
February 2020— R&D UNICANCER 44Survivorship and long term safety : CANcer Toxicities (CANTO)
(Ines Vaz-Luis & F André)
Started in 2012
Inclusions completed with 12,012 patients in 2018
February 2020— R&D UNICANCER 45Survivorship and long term safety : CANcer Toxicities (CANTO)
(Ines Vaz-Luis & F André)
Baseline Follow-up after treatment
Long-term follow-up
Collected Information Diagnosis 3-6 months 12 months 24 months^ 36 months 60 months yearly for 5 years
Inclusion criteria
Signed informed consent
Clinical examination
Prolonged and
Blood tests
long-term toxicity
Paraclinical examination
Survival Outcomes
Questionnaires (PROs)*
Biological samples
*EORTC-QLQ C30, B23, FA12, GPAQ-16, HADS, SF-12, IOCv2, social and financial reports
^telephone-based (remote) assessment of patient follow-up booklet and professional situation
February 2020— R&D UNICANCER 46Survivorship and long term safety : CANcer Toxicities (CANTO)
(Ines Vaz-Luis & F André)
February 2020— R&D UNICANCER 48Survivorship and long term safety : CANcer Toxicities (CANTO)
(Ines Vaz-Luis & F André)
February 2020— R&D UNICANCER 49Plan
Historic
From « Copil Pacs » to UCBG, alliance with GINECO
Actual Organization, numbers
Main strategies and recent achievement
Research interest
International collaboration
Focus on recent realization
Perspectives
Research program
Collaboration
February 2020— R&D UNICANCER 50Research program
Screening/ Prevention
Implementation of MyPebs Program
To develop prevention clinical trials in high risk persons
Adjuvant setting
To build new strategic clinical trials from CANTO data
- Chemo-free regimen (APOLON)
- Reasonnable de-escalation (LESS)
- Chemobrain prevention in young women
To treat at molecular relapses
- cTRACK programme
Metastatic setting
To develop a prospective program on epigenetics
To develop studies for patients progressing on CDK4/6 inhibitor
Consolidation of international collaborations
To consolidate preferential international collaborations (with mainly 3-4
countries: Spain/Portugal/UK/Germany) to foster the development of studies
February 2020— R&D UNICANCER 51Screening: MyPeBS : Suzette Delaloge
This project has received funding from the European Union’s Horizon 2020 research
and innovation programme under grant agreement N° 755394
International Randomized Study
Comparing Personalized, Risk-
Stratified to Standard Breast
Cancer Screening In Women
Aged 40-70
February 2020— R&D UNICANCER 52Screening: MyPeBS : Suzette Delaloge
February 2020— R&D UNICANCER 54Screening: MyPeBS : Suzette Delaloge
Planned accrual – 5 countries
UK 10,000 women / 3 centers
France 20,000 Belgium 10,000 women / 3 regions
women / 30 areas
Italy 30,000 women/ 6 regions
Israël 15,000 women / 11 centres
February 2020— R&D UNICANCER 56Adjuvant setting: Apolon
Aim : To prove that HT + Palbociclib allows for a minimum of 93% iDFS at 3 years
in this “intermediate +” population
Secondary end point : PRO : QOL, depression, fatigue, Physical activity, work, Cognitive function
• pT1/pN0 AND grade 3 or
pT2/pN0 AND histological
grade 2
Letrozol + palbociclib (2 years)
Or:
• pN1 (1-3 N+) AND
histological grade 1/2
Design: Single arm, Non crossing threshold study.
N = 1500
Coordinating investigators : Thomas Bachelot
February 2020— R&D UNICANCER 58Molecular relapse: cTRAK-ER: Collaboration ICR
A randomised phase III trial of early detection
of molecular relapse with circulating tumor
DNA tracking and treatment with palbociclib
Coordinating investigators :
Nicholas TURNER
plus fulvestrant versus standard endocrine
Institute of Cancer Research – London –UK therapy in patients with ER positive HER2
Co-Coordinating investigator : negative breast cancer (cTRAK-ER)
Fabrice ANDRE
Gustave Roussy –Villejuif - France
Biostatistician :
Judith BLISS
Institute of Cancer Research – London –UK
February 2020— R&D UNICANCER 59Molecular relapse: cTRAK-ER: Collaboration ICR
February 2020— R&D UNICANCER 60Metastatic post CDKi: DOLAF Collaboration SOLTI
Molecular
analysis Faslodex +
« HRD+ » 158
Olaparib +
HRD+
BRCA1/2; ATM, Durvalumab
BARD1, BRCA1,
BRCA2, BRIP1,
790 MBC CDK12, CHEK1,
patients CHEK2, FANCA,
ER+/HER2- MBC FAND2, FANCL,
Progressive on MRE11A, NBN,
AI + Palbo PALB2, PPP2R2A,
RAD51B, RAD51C,
HRD - Other
RAD51D, RAD54L,
and TP53 or MSI +
+ ESR1; AKT;
PIK3CA
February 2020— R&D UNICANCER 61Consolidation of international collaborations
International consortium Preferential collaboration
BIG UK : ICR
ALLIANCE Spain : SOLTI
IBCSG… Germany : GBG
=> Regular scientific meetings
=> Constructive discussion
=> Common goal, common project !
February 2020— R&D UNICANCER 62You can also read
