TROPION-Breast04

Section NCT
Category Gynecological tumors / Breast cancer
Subcategory Breast cancer
Trial Type Neoadjuvant Therapy
Description for experts A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
Description for laymen A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
JSON Data { "short_title": "TROPION-Breast04", "data_mode": "900", "data_mode_number": "000002377", "official_title": "Phase 3, Open-Label, Randomized Study of Neoadjuvant Datopotamab Deruxtecan with Durvalumab +/- Chemotherapy followed by Adjuvant Durvalumab, Versus Neoadjuvant Pembrolizumab + Chemotherapy and Adjuvant Pembrolizumab, in Patients with Stage II-III Triple Negative Breast Cancer", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "neoadjuvant", "therapielinie_value": "gtThird", "ctgov_number": "NCT06112379", "eudract_number": null, "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 Studie richtet sich an Patientinnen mit Triple Negativem oder Hormonrezeptor-low, HER2-negativem Brustkrebs, deren Erkrankung noch nicht behandelt wurde.\r\nEs wird untersucht, ob eine Behandlung mit neoadjuvant (vor Operation) Dato-DXd in Kombination mit Durvalumab und adjuvant (nach Operation) folgend Durvalumab mit oder ohne Chemotherapie ein besseres Behandlungsergebnis erzielt als neoadjuvant Pembrolizumab in Kombination mit Chemotherapie und adjuvant folgend Pembrolizumab mit oder ohne Chemotherapie (Standardtherapie).", "description_laie_en": "A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)", "description_expert_de": "Die Studie richtet sich an Patientinnen mit Triple Negativem oder Hormonrezeptor-low, HER2-negativem Brustkrebs, deren Erkrankung noch nicht behandelt wurde.\r\nEs wird untersucht, ob eine Behandlung mit neoadjuvant (vor Operation) Dato-DXd in Kombination mit Durvalumab und adjuvant (nach Operation) folgend Durvalumab mit oder ohne Chemotherapie ein besseres Behandlungsergebnis erzielt als neoadjuvant Pembrolizumab in Kombination mit Chemotherapie und adjuvant folgend Pembrolizumab mit oder ohne Chemotherapie (Standardtherapie).", "description_expert_en": "A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 3, "sub_cat_id": 16 }
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Short name 900-000002377