Clinical Trials

Inclusion 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 marrow function.

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 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 ( e.g., 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/25/23. Questions regarding updates should be directed to the study team contact.