ELEMENT (GBG 114)

Section NCT
Category Gynecological tumors / Breast cancer
Subcategory Breast cancer
Trial Type Follow-Up Treatment (Metastatic Disease)
Description for experts Phase II study evaluating the addition of elacestrant, an oral selective estrogen receptor degrader (SERD), to standard-of-care olaparib in patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutations
Description for laymen Phase II study evaluating the addition of elacestrant, an oral selective estrogen receptor degrader (SERD), to standard-of-care olaparib in patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutations
JSON Data { "short_title": "ELEMENT (GBG 114)", "data_mode": "900", "data_mode_number": "000002476", "official_title": "Phase-II-Studie zur Bewertung der Zugabe von Elacestrant, einem oralen selektiven \u00d6strogenrezeptor-Degrader (SERD), zu Niraparib, einem PARP-Inhibitor, im Vergleich zu Niraparib allein bei Patienten mit Hormonrezeptor (HR)-positiver, HER2-negativer lokal fortgeschrittener oder metastasierter Brust Krebs mit g/tBRCA1/2- und/oder g/tPALB2-Mutationen", "accrual_state": "planned", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "neoadjuvant", "therapielinie_value": "second", "ctgov_number": "NCT06201234", "eudract_number": "2023-504925-38", "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Dr. Theresa Link", "description_laie_de": "Phase-II-Studie zur Pr\u00fcfung der Erg\u00e4nzung von Elacestrant, einem oralen selektiven \u00d6strogenrezeptor-Degrader (SERD), zur Standardtherapie Olaparib bei Patientinnen mit Hormonrezeptor (HR)-positivem, HER2-negativem lokal fortgeschrittenem oder metastasiertem Brustkrebs mit gBRCA1/2-Mutationen", "description_laie_en": "Phase II study evaluating the addition of elacestrant, an oral selective estrogen \r\nreceptor degrader (SERD), to standard-of-care olaparib in patients with \r\nhormone receptor (HR)-positive, HER2-negative locally advanced or metastatic \r\nbreast cancer with gBRCA1/2 mutations", "description_expert_de": "Phase-II-Studie zur Pr\u00fcfung der Erg\u00e4nzung von Elacestrant, einem oralen selektiven \u00d6strogenrezeptor-Degrader (SERD), zur Standardtherapie Olaparib bei Patientinnen mit Hormonrezeptor (HR)-positivem, HER2-negativem lokal fortgeschrittenem oder metastasiertem Brustkrebs mit gBRCA1/2-Mutationen", "description_expert_en": "Phase II study evaluating the addition of elacestrant, an oral selective estrogen \r\nreceptor degrader (SERD), to standard-of-care olaparib in patients with \r\nhormone receptor (HR)-positive, HER2-negative locally advanced or metastatic \r\nbreast cancer with gBRCA1/2 mutations", "rechtsgrundlage_value": "AMG", "phase_amg_value": "II", "main_cat_id": 3, "sub_cat_id": 16 }
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Short name 900-000002476