Abstract PO3-02-02: A prospective, international, observational, real-world evidence database, and collaborative platform for Investigator-Initiated Studies in Early-Stage Breast Cancer tested with MammaPrint and BluePrint– the FLEX Study
Notice bibliographique
Résumé
Abstract TIPS SABCS 2023 A prospective, international, observational, real-world evidence database, and collaborative platform for Investigator-Initiated Studies in Early-Stage Breast Cancer tested with MammaPrint and BluePrint– the FLEX Study Background: Clinical trials have been an invaluable tool in providing improvements in the discovery, treatment, and quality of life for various diseases and disorders including breast cancer, which impacts millions of people each year. The MammaPrint 70-gene assay along with BluePrint 80-gene subtype analysis are tools to provide such improvements in treatment planning. Historically, patient trial populations have not been racially diverse. Current efforts are focused on improving diversity and inclusion to promote efficacy and health equity across all races/ethnicities. Given recent publications supporting the ability of MammaPrint and BluePrint to identify genomic differences in outcomes of black women with breast cancer, the ongoing multi-center FLEX trial (NCT03053193) has proven to be an unparalleled source for improvement in breast cancer care. With a target of 30,000 enrolled patients, the collaborative research network within FLEX will use MammaPrint, BluePrint, full transcriptome, and clinical data to explore clinical and genomic differences in (sub)populations of interest to promote and advance precision medicine for patients with early-stage breast cancer. Methods: FLEX is the first of its kind to link clinical data with full transcriptome data. It is a prospective, observational trial that enrolls patients who are ≥ 18 years old with histologically proven stage I-III breast cancer with up to 3 positive lymph nodes. Patient eligibility for study enrollment include standard of care MammaPrint testing with or without BluePrint and consent to clinically annotated full transcriptome data collection. The study’s infrastructure facilitates the generation of hypotheses for targeted sub-studies that are important for breast cancer management. The FLEX network fosters collaboration with 99 active sites, including Canada, Greece, and Israel. All proposed substudies are vetted and approved by both internal and external research and scientific review committees. Since launching in April 2017, 13,547 patients have been enrolled including those who have been historically underrepresented in trials (Black n =1032; Latin n= 373; AAPI n =276), 43 investigator initiated sub-studies have been approved and are in progress on a varied number of approaches like MammaPrint/Blueprint clinical utilities, racial disparities, neoadjuvant treatment planning in ER+, and or HER2+ breast cancer with 31 abstracts accepted in national and international congresses. Five ongoing sub-studies within FLEX address differences in underlying biology and treatment response/management among Black, Latina, and Asian American patients with early-stage breast cancer. These studies provide a broader understanding of how differential gene expression patterns, identified with MammaPrint and BluePrint, are unique to racial/ethnic groups and can impact treatment outcomes. Overall, the FLEX study strives to use MammaPrint, BluePrint, and newly developed immune signature, ImPrint, along with full transcriptome data to improve precision medicine in early-stage breast cancer. Citation Format: JJ Alberty-Oller, Lee Riley, Laila Samiian, Sarah Thayer, Olexiy Aseyev, Karen Tedesco, Victoria Poillucci, William Audeh, Danijela Jelovac, Joyce O'Shaughnessy. A prospective, international, observational, real-world evidence database, and collaborative platform for Investigator-Initiated Studies in Early-Stage Breast Cancer tested with MammaPrint and BluePrint– the FLEX Study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-02-02.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,045 | 0,140 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,003 |
| Bibliométrie | 0,005 | 0,010 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,007 | 0,004 |
| Science ouverte | 0,004 | 0,006 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,051 | 0,010 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».