An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
Breast Cancer
Unknown Primary
18 - 130 Years, Male and Female
D8535C00001 (primary)
NCI-2023-06834
2023-504031-41-00
Summary
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.
Objectives
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.
Eligibility
- 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
Treatment Sites in Georgia
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