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).
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Looking for Healthy Participants
No
What is Involved?
Description
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
- Answer questionnaires
- Have blood draws
- Have imaging scans
- Have eye exams
- Have heart scans (EKGs)
- Give us permission to use your stored tissue samples
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
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. The study Code is 8485168.
Principal Investigator
Rani
Bansal
Protocol Number
PRO00112971
NCT ID
NCT05774951
Phase
III
Enrollment Status
Open to Enrollment