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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.