This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
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.
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 "
Parallel
Camizestrant
DrugCamizestrant. Experimental. Administered orally
Tamoxifen
DrugTamoxifen. Comparator. Administered orally
Anastrozole
DrugAnastrozole. Comparator. Administered orally
Letrozole
DrugLetrozole. Comparator. Administered orally
Exemestane
DrugExemestane. Comparator. Administered orally
Abemaciclib
DrugAbemaciclib adjuvant treatment Administered orally
Invasive breast cancer-free survival (IBCFS)
IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence * Locoregional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive 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 * Locoregional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive 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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AstraZeneca
Lead sponsor
Austrian Breast & Colorectal Cancer Study Group
Collaborator
