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 cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) 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.
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 high or intermediate risk of recurrence, based on clinical-pathological risk features, 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
Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
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
Parallel
Camizestrant
DrugCamizestrant. Experimental. Administered orally
Tamoxifen
DrugTamoxifen. Comparator. Administered per local approved label
Anastrozole
DrugAnastrozole. Comparator. Administered per local approved label
Letrozole
DrugLetrozole. Comparator. Administered per local approved label
Exemestane
DrugExemestane. Comparator. Administered per local approved label
Invasive breast cancer-free survival (IBCFS)
IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence (invasive IBTR) * Locoregional invasive breast cancer recurrence * Distant recurrence * Invasive contralateral breast cancer * Death attributable to any cause.
Invasive disease-free survival (IDFS)
IDFS is defined as time from randomisation until date of first occurrence of one of the following events: * Invasive ipsilateral breast tumor recurrence (invasive IBTR) * Locoregional invasive breast cancer recurrence * Distant recurrence * Invasive contralateral breast cancer * Second primary non-breast invasive cancer * Death attributable to any cause.
Distant relapse-free survival (DRFS)
DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.
Overall survival (OS)
OS is defined as time from randomisation until death from any cause.
Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
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