ABCSG 62 / CAMBRIA-2
Status: Treatment Phase & Follow-up
A phase III, open-label, randomized study to assess the efficacy and safety of Camizestrant (AZD9833, a next generation, oral selective estrogen receptor degrader) versus standard endocrine therapy (aromatase inhibitor or Tamoxifen) as adjuvant treatment for patients with ER-positive/HER2- negative early breast cancer and an intermediate-high or high risk of recurrence who have completed definitive locoregional treatment and have no evidence of disease.
| Studienstart: | (global): 10/2023; FPI 10/2023 (national): 04/2024 |
| Coordinating Investigator AT: | Daniel Egle, Innsbruck |
| Stichprobenumfang: | 5500 (global), 128 (national) |
| Sponsor: | AstraZeneca |
Description and status:
The phase III global open label trial ABCSG 62 / CAMBRIA-2 is assessing the efficacy and safety of camizestrant (+/- abemaciclib) versus standard endocrine therapy (+/- abemaciclib) as adjuvant treatment for patients with ER-positive/HER2-negative early breast cancer and an intermediate- high or high risk of recurrence, who have completed definitive locoregional treatment and have no evidence of disease.
The CAMBRIA-2 trial is aiming to demonstrate superiority of camizestrant with or without abemaciclib as compared to standard endocrine therapy (ET) with or without abemaciclib by assessment of invasive breast cancer-free survival (IBCFS) as its primary objective. Patients receive 75 mg camizestrant daily, or standard endocrine therapy, for a period of 7 years. A subset of patients – as clinically indicated – will also receive abemaciclib for the first 2 years of treatment, although this proportion is capped at max. 30% of the study population.
Due to the outstanding global enrollment numbers, the recruitment phase ended significantly earlier than originally planned; recruitment concluded on July 1, 2026, with a total of 5,511 patients enrolled. A total of 100 patients were enrolled in the study at 15 participating study sites in Austria. The treatment and follow-up phase of the CAMBRIA-2 study will focus on the treatment and documentation of the participating patients.
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