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

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
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?

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
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.

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
ClinicalTrials.gov