Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany
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RESEARCH ARTICLE
Open Access
Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany Hanna Huebner1†, Christian M. Kurbacher2†, Geoffrey Kuesters3, Andreas D. Hartkopf4, Michael P. Lux5, Jens Huober6, Bernhard Volz7, Florin-Andrei Taran8, Friedrich Overkamp9, Hans Tesch10, Lothar Häberle1,11, Diana Lüftner12, Markus Wallwiener13, Volkmar Müller14, Matthias W. Beckmann1, Erik Belleville15, Matthias Ruebner1, Michael Untch16, Peter A. Fasching1* , Wolfgang Janni6, Tanja N. Fehm17, Hans-Christian Kolberg18, Diethelm Wallwiener4, Sara Y. Brucker4, Andreas Schneeweiss19 and Johannes Ettl20
Abstract Background: Eligibility criteria are a critical part of clinical trials, as they define the patient population under investigation. Besides certain patient characteristics, clinical trials often include biomarker testing for eligibility. However, patient-identification mostly relies on the trial site itself and is often a time-consuming procedure, which could result in missing out on potentially eligible patients. Pre-selection of those patients using a registry could facilitate the process of eligibility testing and increase the number of identified patients. One aim with the PRAEGN ANT registry (NCT02338167) is to identify patients for therapies based on clinical and molecular data. Here, we report eligibility testing for the SHERBOC trial using the German PRAEGNANT registry. Methods: Heregulin (HRG) has been reported to identify patients with better responses to therapy with the antiHER3 monoclonal antibody seribantumab (MM-121). The SHERBOC trial investigated adding seribantumab (MM-121) to standard therapy in patients with advanced HER2-negative, hormone receptor–positive (HR-positive) breast cancer and HRG overexpression. The PRAEGNANT registry was used for identification and tumor testing, helping to link potential HRG positive patients to the trial. Patients enrolled in PRAEGNANT have invasive and metastatic or locally advanced, inoperable breast cancer. Patients eligible for SHERBOC were identified by using the registry. Study aims were to describe the HRG positivity rate, screening procedures, and patient characteristics associated with inclusion and exclusion criteria. (Continued on next page)
* Correspondence: [email protected] † Hanna Huebner and Christian M. Kurbacher contributed equally to this work. 1 Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Erlangen University Hospital, Friedrich-Alexander University Erlangen-Nuremberg, Universitaetsstrasse 21-23, Erlangen 91054, Germany Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes
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