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

Active: Yes
Cancer Type: Breast Cancer
Unknown Primary 		NCT ID: NCT05952557
Trial Phases: Phase III Protocol IDs: D8535C00001 (primary)
NCI-2023-06834
2023-504031-41-00
Eligibility: 18 - 130 Years, Male and Female Study Type: Treatment
Study Sponsor: AstraZeneca Pharmaceuticals LP
NCI Full Details: http://clinicaltrials.gov/show/NCT05952557

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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