Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer

Официальное название

French Prospective Real-life Evaluation of the Endopredict® Genomic Signature for HR-positive,HER2-negative Early Breast Cancer

Обзор

EndoPredict is a genomic signature used to determine the 10-year risk of recurrence in early HR+/HER2- breast cancers classified as of intermediate risk according to conventional clinical and pathological criteria, and to guide the adjuvant treatment decision: hormone therapy alone or hormone therapy and chemotherapy. Since 2016, french laboratories performing the Endopredict test, included prospectively analyzed tumors in the SiMoSein registry with data collection : age, tumor size, lymph node status, histology, grade, HR and HER2 IHC status, Ki67, EPscore, Epclin score, risk of relapse, absolue benefit from chemotherapy, risk of late relapse The main objectives of the trial are to: Evaluate long-term relapse-free survival and overall survival over a 10-year period in breast cancer patients who underwent EndoPredict® testing according to: * EPclin risk class (low vs. high), * Lymph node status (N0/N1), * Tumor size (pT), * Age groups (\<40 years, 40-49 years, 50-69 years, ≥70 years), * EP score alone. This study provide real-life data to determine the clinical usefulness of this molecular signature in the management of early HR+/HER2- breast cancers. The ultimate goal is to be able to offer therapeutic de-escalation (avoiding chemotherapy) to patients who are reliably assessed as having a low risk of relapse.

Вмешательства

• Другое Endopredict test
  Endopredict test was perfomed between 2016 and 2021 in expert french laboratories, for patient with early HR+/HER2-breast cancer presenting insufficient clinical criteria to determine the need for adjuvant chemotherapy, in combination with hormone therapy, after breast surgery. Endopredict is a multigene signature that evaluates, on surgery tumor specimen, the expression of 11 genes (8 genes related to proliferation, apoptosis and HR signal transduction pathways and 3 control genes) by qRT-PCR

Первичные конечные точки

• Survival without relapse [Срок оценки: From the moment where the test is perfomed up to 10 years later.]

Вторичные конечные точки (6)

• Distant recurrence-free survival and overall survival [Срок оценки: From the moment where the test is performed up to 10 years later.]
• Concordance rate between EPclin score and adjuvant treatment administrated [Срок оценки: 10 years after the Endopredict test is perfomed]
• Rate of change in treatment decision related to EPclin outcome [Срок оценки: 10 years after the Endopredict is performed]
• Description of clinical and pathological characteristics [Срок оценки: From the moment where the Endopredict test is performed up to 10 years later]
• Correlation between clinical and pathological characteristics and EndoPredict® test results [Срок оценки: From the moment when the Endopredict test is perfomed to 10 years later]
• EP Score [Срок оценки: 10 year after the Endopredict test is performed]

Критерии участия

Критерии включения

• Patient with early breast cancer, hormone receptor-positive, HER2 non-amplified, for whom clinical criteria are deemed insufficient to determine the need for adjuvant chemotherapy, combined with hormone therapy, after breast surgery.

Критерии исключения

• Patients who did not undergo testing or whose test results were not validated

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Hôpital Saint-Louis — Paris

Публикации

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• Poremba C, Uhlendorff J, Pfitzner BM, Hennig G, Bohmann K, Bojar H, Krenn V, Brase JC, Haufe F, Averdick M, Dietel M, Kronenwett R, Denkert C. Preanalytical variables and performance of diagnostic RNA-based gene expression analysis in breast cancer. Virchows Arch. 2014 Oct;465(4):409-17. doi: 10.1007/s00428-014-1652-0. Epub 2014 Sep 14. PMID 25218890
• Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093. PMID 10963602
• Martin M, Brase JC, Calvo L, Krappmann K, Ruiz-Borrego M, Fisch K, Ruiz A, Weber KE, Munarriz B, Petry C, Rodriguez CA, Kronenwett R, Crespo C, Alba E, Carrasco E, Casas M, Caballero R, Rodriguez-Lescure A. Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM 9906 trial. Breast Cancer Res. 2014 Apr 12;16(2):R38 PMID 24725534
• Muller BM, Brase JC, Haufe F, Weber KE, Budzies J, Petry C, Prinzler J, Kronenwett R, Dietel M, Denkert C. Comparison of the RNA-based EndoPredict multigene test between core biopsies and corresponding surgical breast cancer sections. J Clin Pathol. 2012 Jul;65(7):660-2. doi: 10.1136/jclinpath-2012-200716. Epub 2012 Mar 23. PMID 22447922
• Kronenwett R, Bohmann K, Prinzler J, Sinn BV, Haufe F, Roth C, Averdick M, Ropers T, Windbergs C, Brase JC, Weber KE, Fisch K, Muller BM, Schmidt M, Filipits M, Dubsky P, Petry C, Dietel M, Denkert C. Decentral gene expression analysis: analytical validation of the Endopredict genomic multianalyte breast cancer prognosis test. BMC Cancer. 2012 Oct 5;12:456. doi: 10.1186/1471-2407-12-456. PMID 23039280
• Fitzal F, Filipits M, Rudas M, Greil R, Dietze O, Samonigg H, Lax S, Herz W, Dubsky P, Bartsch R, Kronenwett R, Gnant M. The genomic expression test EndoPredict is a prognostic tool for identifying risk of local recurrence in postmenopausal endocrine receptor-positive, her2neu-negative breast cancer patients randomised within the prospective ABCSG 8 trial. Br J Cancer. 2015 Apr 14;112(8):1405-10. PMID 25867274
• Filipits M, Rudas M, Jakesz R, Dubsky P, Fitzal F, Singer CF, Dietze O, Greil R, Jelen A, Sevelda P, Freibauer C, Muller V, Janicke F, Schmidt M, Kolbl H, Rody A, Kaufmann M, Schroth W, Brauch H, Schwab M, Fritz P, Weber KE, Feder IS, Hennig G, Kronenwett R, Gehrmann M, Gnant M; EP Investigators. A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds indep PMID 21807638

Идентификаторы

NCT: NCT07379918 · APHP251664

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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