ABCSG 62 / CAMBRIA-2 Study Details
CAMBRIA-2: A Phase III, Open-Label, Randomised 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+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease.
| Start: | (global): 10/2023; FPI 10/2023 (national): 04/2024 |
| Coordinating Investigator AT: | Daniel Egle, Innsbruck |
| Sample: | 5500 (global), 144 (national) |
| Study design: (Click to enlarge) |
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Treatment:
Patients will be randomized in a 1:1 ratio into one of the following arms:
Arm A: Standard ET of investigator’s choice (AI [anastrozole, letrozole, or exemestane] or tamoxifen, standard dose per local guidelines, once daily) ± abemaciclib (standard dose as per approved local guidelines or per institutional SoC).
Pre- and peri-menopausal women and men will be treated with either an AI or tamoxifen per investigator’s preference. In pre- and perimenopausal women, concurrent use of an LHRH agonist with either AI or tamoxifen is mandatory. In men, an LHRH agonist is mandatory with AI.
Arm B: Camizestrant (75 mg once daily) ± abemaciclib (standard dose as per approved local guidelines or per institutional SoC).
Pre- and peri-menopausal women and men will require concurrent use of an LHRH agonist.
Primary Objective:
- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of invasive breast cancer-free survival (IBCFS).
Secondary Objectives:
- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of invasive disease-free survival (IDFS).
- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of distant relapse-free survival (DRFS).
- To demonstrate superiority of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of overall survival (OS).
- To demonstrate superior tolerability of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib by assessment of the proportion of time on study treatment with high side-effect burden.
- To assess patient-reported treatment-associated symptoms of arthralgia, hot flush, and vaginal dryness of camizestrant ± abemaciclib as compared to standard ET ± abemaciclib.
- To assess patient-reported health-related QoL in patients treated with camizestrant ± abemaciclib as compared to standard ET ± abemaciclib.
- To assess the steady-state PK of camizestrant in patients who received at least 1 dose of camizestrant per the protocol, for whom there is at least 1 reportable PK concentration.
Patient Population:
- The target population of interest in this study consists of patients with ER+/HER2- early breast cancer with intermediate-high or high risk of recurrence, who have completed definitive locoregional therapy and have no evidence of disease.
- Patients will be designated as having intermediate-high or high risk of recurrence based on clinical and genomic features, including baseline tumor size, number of involved axillary lymph nodes, tumor grade, Ki67, and genomic signature assessment from their medical records, if available.
* Study information is displayed as described in protocol version 2.0 (global version). Sites must always adhere to the currently approved, local version, therefore some information may differ locally.
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