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The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

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.

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.