Abstract 821TiP
Background
In AOC, tumor genomic analyses such as testing for tumor BRCA mutation (tBRCAm) and homologous recombination repair deficiency (HRD) have become essential to select patients (pts) who will derive the greatest benefit from maintenance PARP inhibitor treatment, particularly in first-line. However, a better understanding of specific genomic alterations beyond BRCA and their impact on disease progression is of a critical importance for the next generation drug development and patient outcome improvement.
Trial design
The main objective of GREAT is to build a large database that will allows to correlate the real-life clinical and evolutionary characteristics of AOC pts according to genomic and molecular tumor abnormalities by setting up a tight collaborative network between clinicians, pathologists, biologists and researchers. Eligible pts will have 1st line AOC (FIGO stage 3 or 4), nonmucinous epithelial OC and FFPE tumor specimen available. We planned to include 4500 patients to be able to analyze subgroups representing 1% of all pts (taking account of a dropout rate of 30% secondary to failure of biological analysis or inadequate follow-up). Gene panel tested is described below. Table: 821TiP
| Gene panel | |
| Minimal Core panel | BRCA1 BRCA2 RAD51C RAD51D |
| Extended panel | |
| HRD genes with non-rare and potentially functional mutations | FANCA CDK12 NBN |
| HRD genes with rare or unproven functional mutations | ATM CHEK2 BRIP1 PALB2 Others genes |
| Other genes with potentially actionable mutations | BRAF PI3KCA ARID1A Other targets |
HRD is assessed with Myriad myChoice CDx PLUS® test. Our secondary objectives aim to assess the implementation of tBRCAm test on a nationwide scale as recommended by the French National Cancer institute (INCa) and to participate in the development of future therapeutics by constituting a bank of tumor samples that will allow translational exploratory research. First phase of GREAT will be completed by 2022 with a cohort of 1500 AOC pts treated in the real life with an invaluable collection of biomarkers, clinical data and tumor sample availability. The GREAT cohort will offer a unique opportunity for current and future drug development evaluation.
Clinical trial identification
NCT04027868.
Editorial acknowledgement
Legal entity responsible for the study
ARCAGY-GINECO.
Funding
ARCAGY GINECO and AstraZeneca.
Disclosure
E. Kalbacher: Financial Interests, Personal, Advisory Role: GSK Tesaro; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Pharmamar; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Leopharma; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Personal, Advisory Role: Sanofi. B. Asselain: Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Daiichi; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Servier; Financial Interests, Personal, Advisory Role: Pierre Fabre. M. Rodrigues: Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Other: AstraZeneca. L. Bengrine Lefevre: Financial Interests, Personal, Other, Board: AstraZeneca; Financial Interests, Personal, Other, Board: Clovis; Financial Interests, Personal, Other, Scientific meeting: GSK; Non-Financial Interests, Personal, Other, Scientific comity member: SOFOG. E. Rouleau: Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: BMS; Financial Interests, Personal, Other: Clovis. C. Nogues: Non-Financial Interests, Other, President: Unicancer Genetics Group; Non-Financial Interests, Other, Secretary: Human Genetics; Non-Financial Interests, Other, Scientific Board: Europa Donna; Non-Financial Interests, Other, Scientific Board: Geneticancer. A. Morel: Financial Interests, Personal, Other, Board and project: AstraZeneca; Financial Interests, Personal, Other, Board: Novartis; Financial Interests, Personal, Other, Board: BMS; Financial Interests, Personal, Other, Board: GSK. R. Boidot: Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Bayer; Financial Interests, Personal, Other: Illumina; Financial Interests, Personal, Other: Boehringer Ingelheim. L. Arnould: Financial Interests, Personal, Other, Speaker and consulting: Roche; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Other, Consulting: Daiichi; Financial Interests, Personal, Other, Speaker and consulting: AstraZeneca. E. Pujade-Lauraine: Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Clovis; Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Other: Gemmab; Financial Interests, Personal, Other, CEO: ARCAGY Research; Financial Interests, Institutional, Other: AstraZeneca; Financial Interests, Institutional, Other: Roche; Non-Financial Interests, Other, Medical director: ARCAGY GINECO. All other authors have declared no conflicts of interest.