Cambria 1 for ER+/HER2- Early Stage Breast Cancer after Surgery - Clinical Trial

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. The study Code is 8485168.

Principal Investigator