Dataset for the Pearl study
Biomarkers to identify patients without benefit from adding everolimus to endocrine treatment in metastatic breast cancer (MBC) are needed. We report the results of the Pearl trial conducted in five Belgian centers assessing 18F-FDG-PET/CT non-response (n=45) and ctDNA detection (n=46) after 14 days of exemestane-everolimus (EXE-EVE) to identify MBC patients who will not benefit. Metabolic non-response rate was 66.6%. Median PFS in non-responding patients (using as cut-off 25% for SUVmax decrease) was 3.1 months compared to 6.0 months in those showing response (HR: 0.77, 95% CI: 0.40-1.50, p=0.44). Difference was significant when using a “post-hoc” cut-off of 15% (PFS 2.2 months vs 6.4 months). ctDNA detection at D14 was associated with PFS: 2.1 months vs 5.0 months (HR-2.5, 95% CI: 1.3-5.0, p=0.012). Detection of ctDNA and/or the absence of 18F-FDG-PET/CT response after 14 days of EXE-EVE identifies patients with a low probability of benefiting from treatment. Independent validation is needed.
- 126 samples
- DAC: EGAC00001002255
- Technology: Ion Torrent S5 XL
Data policy for Pearl
DATA ACCESS AGREEMENT These terms and conditions govern access to the managed access dataset to which the User has requested access. The User agrees to be bound by these terms and conditions. Definitions: Data means all and any human genetic data obtained from this study/dataset. User means a researcher who has previously completed the Data Access Agreement. User Institution means the organisation at which the User is employed, affiliated or enrolled. Publications means, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research. Terms and Conditions: In signing this Agreement: You agree to use the Data only for research purposes. You agree to preserve, at all times, the confidentiality of information and Data. You agree not to transfer or disclose the Data, in whole or part, or any identifiable material derived from the Data, to others, except as necessary for data/safety monitoring or programme management. Should You wish to share the Data with a collaborator outwith the same Institution, the third party must make a separate application for access to the Data. You agree to use the data for the approved purpose and project described in your application; use of the data for a new purpose or project will require a new application and approval. You agree to acknowledge in any work based in whole or part on the Data, the published paper from which the Data derives. You understand and acknowledge that the Data is protected by copyright and other intellectual property rights, and that duplication, except as reasonably required to carry out Your research with the Data, or sale of all or part of the Data on any media is not permitted. You recognise that nothing in this agreement shall operate to transfer to the User Institution any intellectual property rights relating to the Data. You accept that this agreement will terminate immediately upon any breach of this agreement by You and You will be required to destroy any Data held.
Studies are experimental investigations of a particular phenomenon, e.g., case-control studies on a particular trait or cancer research projects reporting matching cancer normal genomes from patients.
| Study ID | Study Title | Study Type |
|---|---|---|
| EGAS00001005523 | Cancer Genomics |
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