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:<ul>
<li>Are diagnosed with intermediate or high-risk early stage ER+/HER2- breast cancer</li>
<li>Have had surgery to remove breast cancer tissue</li>
<li>Have been taking endocrine therapy for 2-5 years after surgery</li></ul>
For more information about who can join this study, please contact the study team at caroline.morales@duke.edu.
<li>Are diagnosed with intermediate or high-risk early stage ER+/HER2- breast cancer</li>
<li>Have had surgery to remove breast cancer tissue</li>
<li>Have been taking endocrine therapy for 2-5 years after surgery</li></ul>
For more information about who can join this study, please contact the study team at caroline.morales@duke.edu.
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Looking for Healthy Participants
No
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:<ul>
<li>One group will take physician's choice endocrine therapy daily</li>
<li>The other group will take camizestrant daily</li></ul>
Participants in both groups will:<ul>
<li>Answer questionnaires</li>
<li>Have blood draws</li>
<li>Have imaging scans</li>
<li>Have eye exams</li>
<li>Have heart scans (EKGs)</li>
<li>Give us permission to use your stored tissue samples</li></ul>
After study treatment, you will continue to return to our clinic for follow-up visits to see how you are doing.
<li>One group will take physician's choice endocrine therapy daily</li>
<li>The other group will take camizestrant daily</li></ul>
Participants in both groups will:<ul>
<li>Answer questionnaires</li>
<li>Have blood draws</li>
<li>Have imaging scans</li>
<li>Have eye exams</li>
<li>Have heart scans (EKGs)</li>
<li>Give us permission to use your stored tissue samples</li></ul>
After study treatment, you will continue to return to our clinic for follow-up visits to see how you are doing.
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
Principal Investigator
Carey
Anders
Protocol Number
PRO00112971
NCT ID
NCT05774951
Phase
III
Enrollment Status
Open to Enrollment