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

Invasive breast cancer-free survival (IBCFS)

Timeframe: Up to 14 years

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)

Timeframe: Up to 14 years

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)

Timeframe: Up to 14 years

DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.

Overall survival (OS)

Timeframe: Up to 14 years

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)

Timeframe: Until 28 days after the final dose of study treatment (up to 7 years)

Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT.

Timeframe: Until 28 days after the final dose of study treatment (up to 7 years)

Change from baseline and time to deterioration of health-related quality of life as measured by the 2 global QoL items from the EORTC IL-311

Timeframe: Until 28 days after the final dose of study treatment (up to 7 years)

Pharmacokinetics (PK)

Timeframe: Until 6 months from treatment start

Plasma concentrations of camizestrant pre-dose (trough concentration)