TREAT ctDNA

The study investigates whether treatment with elacestrant (an oral selective estrogen receptor degrader: SERD) leads to better treatment outcomes compared to standard antihormonal therapy. During the ctDNA screening phase, patient blood samples are regularly tested for circulating tumor DNA (ctDNA, so-called liquid biopsy). If ctDNA is detected, patients without evidence of distant metastases receive antihormonal therapy. This is a randomized study. Patients receive either elacestrant (oral) or standard antihormonal therapy

{ "short_title": "TREAT ctDNA", "data_mode": "900", "data_mode_number": "000002442", "official_title": "Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "first", "ctgov_number": "NCT05512364", "eudract_number": "2022-501453-36", "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Dr. Theresa Link", "description_laie_de": "Es wird untersucht, ob eine Therapie mit Elacestrant (ein oraler selektiver \u00d6strogenrezeptor-Degrader: SERD) im Vergleich zur antihormonellen Standardtherapie zu besseren Behandlungsergebnissen f\u00fchrt.\r\n\r\nW\u00e4hrend der ctDNA-Screening-Phase werden regelm\u00e4\u00dfig Blutproben der PatientInnen auf zirkulierende Tumor-DNA (ctDNA, sog. Liquid Biopsy) untersucht. Bei Nachweis von ctDNA erhalten PatientInnen ohne Hinweis auf Fernmetastasen eine antihormonelle Therapie.\r\n\r\nEs handelt sich um eine randomisierte Studie. Die PatientInnen erhalten entweder\r\n\r\nElacestrant (oral) oder\r\nAntihormonelle Standardtherapie", "description_laie_en": "The study investigates whether treatment with elacestrant (an oral selective estrogen receptor degrader: SERD) leads to better treatment outcomes compared to standard antihormonal therapy.\r\n\r\nDuring the ctDNA screening phase, patient blood samples are regularly tested for circulating tumor DNA (ctDNA, so-called liquid biopsy). If ctDNA is detected, patients without evidence of distant metastases receive antihormonal therapy.\r\n\r\nThis is a randomized study. Patients receive either\r\n\r\nelacestrant (oral) or\r\n\r\nstandard antihormonal therapy", "description_expert_de": "Es wird untersucht, ob eine Therapie mit Elacestrant (ein oraler selektiver \u00d6strogenrezeptor-Degrader: SERD) im Vergleich zur antihormonellen Standardtherapie zu besseren Behandlungsergebnissen f\u00fchrt.\r\n\r\nW\u00e4hrend der ctDNA-Screening-Phase werden regelm\u00e4\u00dfig Blutproben der PatientInnen auf zirkulierende Tumor-DNA (ctDNA, sog. Liquid Biopsy) untersucht. Bei Nachweis von ctDNA erhalten PatientInnen ohne Hinweis auf Fernmetastasen eine antihormonelle Therapie.\r\n\r\nEs handelt sich um eine randomisierte Studie. Die PatientInnen erhalten entweder\r\n\r\nElacestrant (oral) oder\r\nAntihormonelle Standardtherapie", "description_expert_en": "The study investigates whether treatment with elacestrant (an oral selective estrogen receptor degrader: SERD) leads to better treatment outcomes compared to standard antihormonal therapy.\r\n\r\nDuring the ctDNA screening phase, patient blood samples are regularly tested for circulating tumor DNA (ctDNA, so-called liquid biopsy). If ctDNA is detected, patients without evidence of distant metastases receive antihormonal therapy.\r\n\r\nThis is a randomized study. Patients receive either\r\n\r\nelacestrant (oral) or\r\n\r\nstandard antihormonal therapy", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 3, "sub_cat_id": 16 }