Cambria 1 for ER+/HER2- Early Stage Breast Cancer after Surgery
What is the Purpose of this Study?
We are doing this study to determine if long-term treatment with camizestrant after surgery is a safe and effective option for treating patients with early-stage ER+/HER2- breast cancer. We want to compare the outcomes of using camizestrant to current standard of care treatments (endocrine therapy).
What is the Condition Being Studied?
Early Stage ER+/HER2- Breast Cancer
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with intermediate or high-risk early stage ER+/HER2- breast cancer
- Have had surgery to remove breast cancer tissue
- Have been taking endocrine therapy for 2-5 years after surgery
For more information about who can join this study, please contact the study team at caroline.morales@duke.edu.
Age Group
Adults
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- One group will take physician's choice endocrine therapy daily
- The other group will take camizestrant daily
Participants in both groups will:
- Answer questionnaires
- Have blood draws
- Have imaging scans
- Have eye exams
- Have heart scans (EKGs)
- Give us permission to use your stored tissue samples
After study treatment, you will continue to return to our clinic for follow-up visits to see how you are doing.
Study Details
Full Title
CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence
Principal Investigator
Professor of Medicine
Protocol Number
IRB:
PRO00112971
NCT:
NCT05774951
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL
Participate
Call 919-660-1278