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.
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 of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5,500
Camizestrant. Experimental. Administered orally
Tamoxifen. Comparator. Administered orally
Anastrozole. Comparator. 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.
Time frame: Up to 14 years
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.
Time frame: Up to 14 years
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.
Time frame: Up to 14 years
Overall survival (OS)
OS is defined as time from randomisation until death from any cause.
Time frame: Up to 14 years
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)
Time frame: 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.
Time frame: 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
AstraZeneca Clinical Study Information Center
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Letrozole. Comparator. Administered orally
Exemestane. Comparator. Administered orally
Abemaciclib adjuvant treatment Administered orally
Research Site
Dothan, Alabama, United States
RECRUITINGResearch Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Tucson, Arizona, United States
RECRUITINGResearch Site
Fayetteville, Arkansas, United States
RECRUITINGResearch Site
Duarte, California, United States
RECRUITINGResearch Site
Fountain Valley, California, United States
RECRUITINGResearch Site
Greenbrae, California, United States
NOT_YET_RECRUITINGResearch Site
Irvine, California, United States
RECRUITINGResearch Site
La Jolla, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
RECRUITING...and 784 more locations
Time frame: Until 28 days after the final dose of study treatment (up to 7 years)
Pharmacokinetics (PK)
Plasma concentrations of camizestrant pre-dose (trough concentration)
Time frame: Until 6 months from treatment start