CAMBRIA-1

{ "short_title": "CAMBRIA-1", "data_mode": "900", "data_mode_number": "000002346", "official_title": "CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "neoadjuvant", "therapielinie_value": "first", "ctgov_number": "NCT05774951", "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": "Eine Studie zu Camizestrant bei ER+/HER2-Brustkrebs im Fr\u00fchstadium nach mindestens 2 Jahren zus\u00e4tzlicher endokriner Standardtherapie.\r\n\r\nDie Zielpopulation in dieser Studie besteht aus Patientinnen mit ER+/HER2-Brustkrebs im Fr\u00fchstadium, die eine definitive lokoregion\u00e4re Therapie abgeschlossen haben und mindestens 2 Jahre lang eine zus\u00e4tzliche Standard-ET mit oder ohne Cyclin-abh\u00e4ngigem Kinase-4- und -6(CDK4/6)-Inhibitor erhalten haben und derzeit krankheitsfrei sind, jedoch ein mittleres oder hohes Rezidivrisiko tragen.", "description_laie_en": "A study of camizestrant in ER+/HER2- early breast cancer after at least 2 years of additional standard endocrine therapy.\r\n\r\nThe target population for this study consists of patients with ER+/HER2- early breast cancer who have completed definitive locoregional therapy and received at least 2 years of additional standard endocrine therapy with or without a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor and are currently disease-free but at intermediate or high risk of recurrence.", "description_expert_de": "n dieser offenen Phase-III-Studie soll untersucht werden, ob Camizestrant die Behandlungsergebnisse im Vergleich zur Standard-Hormontherapie bei Patientinnen mit ER-positivem/HER2-Brustkrebs im Fr\u00fchstadium mit mittlerem oder hohem Rezidivrisiko verbessert, die eine definitive lokoregionale Therapie (mit oder ohne Chemotherapie) und eine standardm\u00e4\u00dfige adjuvante endokrine Therapie (ET) f\u00fcr mindestens zwei bis maximal f\u00fcnf Jahre abgeschlossen haben. Die geplante Behandlungsdauer in beiden Studienarmen betr\u00e4gt 60 Monate.", "description_expert_en": "This is a Phase III open-label study to assess if camizestrant improves outcomes comparedto standard endocrine therapy in patients with ER+/HER2 - early breast cancer withintermediate or high risk for disease recurrence who completed definitive locoregionaltherapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) forat least 2 years and up to 5 years. The planned duration of treatment in either arm ofthe study is 60 months.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "I", "main_cat_id": 3, "sub_cat_id": 16 }