ABCSG 60 / CAMBRIA-1
Status: Treatment Phase & Follow-up
A phase III, open-label, randomized study to assess the efficacy and safety of extended therapy with Camizestrant versus standard endocrine therapy in patients with ER+/HER2- early breast cancer and an intermediate or high risk of recurrence who have completed at least 2 years of standard adjuvant endocrine-based therapy without disease recurrence
| Coordinating Investigator: | Daniel Egle, Innsbruck |
| Start of study: | (global): 04/2023 (national): 08/2023 |
| Sample size: | 4.300 |
| Sponsor: | |
| Study design: (Click to enlarge) |
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Description and status:
The ABCSG 60 / CAMBRIA-1 trial is an open, randomized phase III study evaluating the efficacy and safety of camizestrant in comparison to standard endocrine therapy in HR+/HER2- early breast cancer patients with an intermediate to high risk of recurrence. Patients must have completed definitive locoregional therapy and at least 2 years of standard endocrine therapy without disease recurrence at time of enrollment and at least another 5 years of standard endocrine therapy treatment must be foreseen. The primary endpoint of CAMBRIA-1 is to demonstrate superiority of extended therapy with camizestrant as compared to standard endocrine therapy by assessment of invasive breast cancer-free survival (IBCFS). Patients receive 75 mg camizestrant daily or continue their standard endocrine therapy for 5 years. Subsequently, patients will be followed-up for a total of approximately 10 years after randomization.
Thanks to outstanding global enrolment, the actual recruitment phase was considerably shorter than originally projected. Only a limited number of sites are still actively recruiting for the trial to fulfil specific regulatory requirements. Screening was closed for all other sites and countries as of 17 April 2025. The last CAMBRIA-1 patient in Austria was recruited on 13 May 2025. During the recruitment phase, 133 patients were successfully recruited throughout 14 Austrian sites. The treatment and follow-up phases of CAMBRIA-1 will focus on patient retention while consistently treating, caring for, and monitoring patients until the study’s completion in 2035.
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