This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria.
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The purpose of this study is to determine whether treatment with OP-1250 as a monotherapy will result in improvement of progression-free survival (PFS) and overall survival (OS) compared to SOC ET and assess the safety of treatment with OP-1250 in participants with ER+, HER2– advanced or MBC with and without estrogen receptor 1 gene (ESR1) activating mutation(-s) whose disease has relapsed or progressed on 1 or 2 prior lines of SOC ET, including a cyclin-dependent kinase (CDK) 4/6 inhibitor.
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