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

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 bone 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 ( 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.