Brief Summary
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 cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs with intermediate or high riskthe possibility that something bad will happen for disease recurrenceto occur or happen again who completed definitive locoregional therapy (with or without chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
Intervention / Treatment
- Drug: Camizestrant
- Drug: Tamoxifen
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
Inclusion Criteria:
- Women and Men, ≥18 years at the time of screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening (or per national guidelines)
- Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.
- Completed adequate (definitive) locoregional therapy (surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapychemotherapy given after primary treatment, such as surgery, to reduce the risk of your cancer coming back
- Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of ≤ 1
- Adequate organ and marrow function.