An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Eligibility Criteria

• * Women and Men; ≥18 years at the time of screening (or per national guidelines)
• * Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
• * Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
• * Patients must be randomised within 12 months of definitive breast surgery.
• * Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
• * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• * Adequate organ and bone marrow function
• * 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 a 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 reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
• * 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.