A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

Exclusion Criteria

• •Inoperable locally advanced or metastatic breast cancer
• •Pathological complete response following treatment with neoadjuvant therapy
• •History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
• •Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance
• •Known LVEF \<50% with heart failure NYHA Grade ≥2.
• •Mean resting QTcF interval \>480 ms at screening
• •Concurrent exogenous sex hormone therapy
• •Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)
• •Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
• •Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding
• •Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist