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
Assistant Professor of Medicine
Protocol Number
IRB: PRO00112971
NCT: NCT05774951
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL