Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany.
- Huebner H Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Erlangen University Hospital, Friedrich-Alexander University Erlangen-Nuremberg, Universitaetsstrasse 21-23, Erlangen, 91054, Germany.
- Kurbacher CM Gynecology I (Gynecologic Oncology), Gynecologic Center Bonn-Friedensplatz, Bonn, Germany.
- Kuesters G Merrimack Pharmaceuticals, Cambridge, MA, USA.
- Hartkopf AD Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
- Lux MP Klinik für Gynäkologie und Geburtshilfe Frauenklinik St. Louise, Paderborn, St. Josefs-Krankenhaus, Salzkotten, Kooperatives Brustzentrum, Paderborn, Germany.
- Huober J Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
- Volz B Ansbach University of Applied Sciences, Ansbach, Germany.
- Taran FA Department of Gynecology, Zurich University Hospital, Zurich, Switzerland.
- Overkamp F Oncologianova GmbH, Recklinghausen, Germany.
- Tesch H Oncology Practice at Bethanien Hospital Frankfurt, Frankfurt, Germany.
- Häberle L Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Erlangen University Hospital, Friedrich-Alexander University Erlangen-Nuremberg, Universitaetsstrasse 21-23, Erlangen, 91054, Germany.
- Lüftner D Berlin, Campus Benjamin Franklin, Department of Hematology, Oncology and Tumor Immunology, Charité University Hospital, Berlin, Germany.
- Wallwiener M Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg, Germany.
- Müller V Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany.
- Beckmann MW Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Erlangen University Hospital, Friedrich-Alexander University Erlangen-Nuremberg, Universitaetsstrasse 21-23, Erlangen, 91054, Germany.
- Belleville E ClinSol GmbH & Co KG, Würzburg, Germany.
- Ruebner M Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Erlangen University Hospital, Friedrich-Alexander University Erlangen-Nuremberg, Universitaetsstrasse 21-23, Erlangen, 91054, Germany.
- Untch M Department of Gynecology and Obstetrics, Helios Clinics Berlin Buch, Berlin, Germany.
- Fasching PA Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Erlangen University Hospital, Friedrich-Alexander University Erlangen-Nuremberg, Universitaetsstrasse 21-23, Erlangen, 91054, Germany. peter.fasching@fau.de.
- Janni W Department of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
- Fehm TN Department of Gynecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Germany.
- Kolberg HC Department of Gynecology and Obstetrics, Marienhospital Bottrop, Bottrop, Germany.
- Wallwiener D Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
- Brucker SY Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
- Schneeweiss A National Center for Tumor Diseases and Department of Gynecology and Obstetrics, Heidelberg University Hospital, Heidelberg, Germany.
- Ettl J Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
- 2020-11-12
Published in:
- BMC cancer. - 2020
English
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 PRAEGNANT 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 anti-HER3 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.
RESULTS
Among 2769 unselected advanced breast cancer patients, 650 were HER2-negative, HR-positive and currently receiving first- or second-line treatment, thus potentially eligible for SHERBOC at the end of current treatment; 125 patients also met further clinical eligibility criteria (e.g. menopausal status, ECOG). In the first/second treatment lines, patients selected for SHERBOC based on further eligibility criteria had a more favorable prognosis than those not selected. HRG status was tested in 38 patients, 14 of whom (36.8%) proved to be HRG-positive.
CONCLUSION
Using a real-world breast cancer registry allowed identification of potentially eligible patients for SHERBOC focusing on patients with HER3 overexpressing, HR-positive, HER2-negative metastatic breast cancer. This approach may provide insights into differences between patients eligible or non-eligible for clinical trials.
TRIAL REGISTRATION
Clinicaltrials, NCT02338167 , Registered 14 January 2015 - retrospectively registered.
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 PRAEGNANT 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 anti-HER3 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.
RESULTS
Among 2769 unselected advanced breast cancer patients, 650 were HER2-negative, HR-positive and currently receiving first- or second-line treatment, thus potentially eligible for SHERBOC at the end of current treatment; 125 patients also met further clinical eligibility criteria (e.g. menopausal status, ECOG). In the first/second treatment lines, patients selected for SHERBOC based on further eligibility criteria had a more favorable prognosis than those not selected. HRG status was tested in 38 patients, 14 of whom (36.8%) proved to be HRG-positive.
CONCLUSION
Using a real-world breast cancer registry allowed identification of potentially eligible patients for SHERBOC focusing on patients with HER3 overexpressing, HR-positive, HER2-negative metastatic breast cancer. This approach may provide insights into differences between patients eligible or non-eligible for clinical trials.
TRIAL REGISTRATION
Clinicaltrials, NCT02338167 , Registered 14 January 2015 - retrospectively registered.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s12885-020-07546-1
- PMID 33176725
- Persistent URL
- https://sonar.ch/global/documents/33258
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