COGNITION-GUIDE

Section NCT
Category Gynecological tumors / Breast cancer
Subcategory Breast cancer
Trial Type Neoadjuvant Therapy
Description for experts The trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials. Eligible patients are identified considering pCR-status and clinical stage estrogen receptor status grade (CPS-EG)-score following surgery after neoadjuvant therapy. Allocation to the therapy- arms is conducted by a molecular tumor board based on in depth molecular characterization of tumors within the COGNITION registry program. Recruitment of adequate patient numbers in well-defined molecular subgroups is achieved in a multicenter approach. The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm. The primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.
Description for laymen The trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials. Eligible patients are identified considering pCR-status and clinical stage estrogen receptor status grade (CPS-EG)-score following surgery after neoadjuvant therapy. Allocation to the therapy- arms is conducted by a molecular tumor board based on in depth molecular characterization of tumors within the COGNITION registry program. Recruitment of adequate patient numbers in well-defined molecular subgroups is achieved in a multicenter approach. The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm. The primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.
JSON Data { "short_title": "COGNITION-GUIDE", "data_mode": "900", "data_mode_number": "000002349", "official_title": "Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer - a Multicenter, Open-label, Umbrella Phase-II Study - COGNITION-GUIDE", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "neoadjuvant", "therapielinie_value": "first", "ctgov_number": "NCT05332561", "eudract_number": "2020-002606-22", "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger", "description_laie_de": "Die sieben-armige COGNITION-GUIDE Phase II-Studie hat das Ziel, im Rahmen der \r\nPr\u00e4zisionsonkologie im fr\u00fchen, potentiell kurativ behandelbaren Krankheitsstadium durch eine \r\nzus\u00e4tzliche, molekular stratifizierte post-neoadjuvante Therapie die Behandlung von \r\nBrustkrebspatientinnen mit hohem Rezidiv- und Metastasierungsrisiko zu verbessern. \r\nDie Studie pr\u00fcft den Nutzen der Pr\u00e4zisionsonkologie mit Translation in molekular zielgerichteten \r\nTherapieans\u00e4tzen in einem potentiell kurativen Krankheitsstadium als Grundlage f\u00fcr zuk\u00fcnftige \r\nkonfirmatorische Biomarker-basierte randomisierte interventionelle Studien. \r\nGeeignete Patientinnen und Patienten werden mittels pathologischer Evaluation nach OP und \r\nCPS-EG-Score nach neoadjuvanter Therapie und Operation identifiziert und nach eingehender \r\nmolekularer Charakterisierung der Tumoren im Rahmen des COGNITION-Register-Programms \r\nvon einem molekularen Tumorboard verschiedenen Behandlungsarmen zugeteilt. Die \r\nRekrutierung ad\u00e4quater Fallzahlen in klar definierten molekularen Untergruppen wird in einem \r\nmultizentrischen Ansatz erreicht. \r\nDie Studie pr\u00fcft, ob ein Gesamtnutzen des pr\u00e4zisionsmedizinischen Ansatzes bei Hochrisiko-\r\neBC-Patient:innen erreicht werden kann und erm\u00f6glicht eine explorative Evaluation der einzelnen \r\nStudienarme. \r\nPrim\u00e4rer Endpunkt der Studie ist das invasive krankheitsfreie \u00dcberleben (Invasive Disease Free \r\nSurvival, IDFS) nach 4 Jahren (von der Operation bis zum lokalen Rezidiv, Metastasierung oder \r\nTod). Die Fallzahl der gesamten Studie betr\u00e4gt 240 eingeschlossene Patient:innen.", "description_laie_en": "The trial evaluates not a single drug but rather a general strategy of precision oncology in the \r\ncurative setting and provides the basis for future confirmatory biomarker-driven trials. \r\nEligible patients are identified considering pCR-status and clinical stage estrogen receptor status \r\ngrade (CPS-EG)-score following surgery after neoadjuvant therapy. Allocation to the therapy-\r\narms is conducted by a molecular tumor board based on in depth molecular characterization of \r\ntumors within the COGNITION registry program. Recruitment of adequate patient numbers in \r\nwell-defined molecular subgroups is achieved in a multicenter approach. \r\nThe study aims to show an overall benefit of the precision medicine approach in high-risk eBC \r\npatients and to allow for secondary exploratory evaluation of each study-arm. \r\nThe primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years \r\nmeasured from surgery to local or distant relapse or death. The sample size of the entire trial is \r\n240 eligible patients.", "description_expert_de": "Die sieben-armige COGNITION-GUIDE Phase II-Studie hat das Ziel, im Rahmen der \r\nPr\u00e4zisionsonkologie im fr\u00fchen, potentiell kurativ behandelbaren Krankheitsstadium durch eine \r\nzus\u00e4tzliche, molekular stratifizierte post-neoadjuvante Therapie die Behandlung von \r\nBrustkrebspatientinnen mit hohem Rezidiv- und Metastasierungsrisiko zu verbessern. \r\nDie Studie pr\u00fcft den Nutzen der Pr\u00e4zisionsonkologie mit Translation in molekular zielgerichteten \r\nTherapieans\u00e4tzen in einem potentiell kurativen Krankheitsstadium als Grundlage f\u00fcr zuk\u00fcnftige \r\nkonfirmatorische Biomarker-basierte randomisierte interventionelle Studien. \r\nGeeignete Patientinnen und Patienten werden mittels pathologischer Evaluation nach OP und \r\nCPS-EG-Score nach neoadjuvanter Therapie und Operation identifiziert und nach eingehender \r\nmolekularer Charakterisierung der Tumoren im Rahmen des COGNITION-Register-Programms \r\nvon einem molekularen Tumorboard verschiedenen Behandlungsarmen zugeteilt. Die \r\nRekrutierung ad\u00e4quater Fallzahlen in klar definierten molekularen Untergruppen wird in einem \r\nmultizentrischen Ansatz erreicht. \r\nDie Studie pr\u00fcft, ob ein Gesamtnutzen des pr\u00e4zisionsmedizinischen Ansatzes bei Hochrisiko-\r\neBC-Patient:innen erreicht werden kann und erm\u00f6glicht eine explorative Evaluation der einzelnen \r\nStudienarme. \r\nPrim\u00e4rer Endpunkt der Studie ist das invasive krankheitsfreie \u00dcberleben (Invasive Disease Free \r\nSurvival, IDFS) nach 4 Jahren (von der Operation bis zum lokalen Rezidiv, Metastasierung oder \r\nTod). Die Fallzahl der gesamten Studie betr\u00e4gt 240 eingeschlossene Patient:innen.", "description_expert_en": "The trial evaluates not a single drug but rather a general strategy of precision oncology in the \r\ncurative setting and provides the basis for future confirmatory biomarker-driven trials. \r\nEligible patients are identified considering pCR-status and clinical stage estrogen receptor status \r\ngrade (CPS-EG)-score following surgery after neoadjuvant therapy. Allocation to the therapy-\r\narms is conducted by a molecular tumor board based on in depth molecular characterization of \r\ntumors within the COGNITION registry program. Recruitment of adequate patient numbers in \r\nwell-defined molecular subgroups is achieved in a multicenter approach. \r\nThe study aims to show an overall benefit of the precision medicine approach in high-risk eBC \r\npatients and to allow for secondary exploratory evaluation of each study-arm. \r\nThe primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years \r\nmeasured from surgery to local or distant relapse or death. The sample size of the entire trial is \r\n240 eligible patients.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "II", "main_cat_id": 3, "sub_cat_id": 16 }
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Short name 900-000002349