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

- 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
Medical Oncologist
Protocol Number
IRB: PRO00112971
NCT: NCT05774951
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment