ABCSG 60 / CAMBRIA-1 Study Details

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.

Start:	(global): 03/2023; FPI 04/2023 (national): 07/2023
Coordinating Investigator AT:	Daniel Egle, Innsbruck
Sample:	4300 (global), 100 (national)
Study design: (Click to enlarge)

Treatment:

Patients will be randomized in a 1:1 ratio to one of the following arms

Arm A
Continue the standard ET of investigator’s choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen, standard dose per investigator, once daily) with or without luteinising hormone-releasing hormone (LHRH) agonist(s)

Arm B
Camizestrant (75 mg, once daily) with or without LHRH agonist(s)

Primary objective:

To demonstrate superiority of extended therapy with camizestrant as compared to standard ET by assessment of invasive breast cancer-free survival

Secondary objectives:

To demonstrate superiority of extended therapy with camizestrant as compared to standard ET by assessment of invasive disease-free survival
To demonstrate superiority of extended therapy with camizestrant as compared to standard ET by assessment of distant relapse-free survival
To demonstrate superiority of extended therapy with camizestrant as compared to standard ET by assessment of overall survival
To assess the safety of extended therapy with camizestrant as compared to standard ET
To assess patient-reported treatment associated symptoms of arthralgia, hot flush, and vaginal dryness of camizestrant as compared to standard ET.
To assess patient-reported health-related QoL in patients treated with extended therapy with camizestrant relative to standard ET
To assess the steady-state PK of camizestrant in patients who received at least one dose of camizestrant per the protocol, for whom there is at least one reportable PK concentration.

Patient Population:

The target population of interest in this study consists of patients with ER+/HER2- early breast cancer with intermediate or high risk of recurrence, who have completed definitive locoregional therapy and at least 2 years and up to 5 years (+3 months) of standard adjuvant ET with no disease recurrence.
Patients may have received (neo)adjuvant CDK4/6 inhibitors prior to study entry.
Patients will be designated as having intermediate or high risk of recurrence based on clinical and genomic features, including baseline tumor size, grade, number of involved axillary lymph nodes, prior chemotherapy, and genomic signature assessment from their medical records, if available.
Recruitment of patients with T1c-T2, N0 and at least one of the following features: Grade 3; pre-existing high risk of recurrence per genomic signature assessment from medical record if in compliance with local regulations and conducted in accordance with intended use; or centrally assessed Ki-67 ≥20% via an AstraZeneca-provided laboratory test will be capped at approximately 30% of the total randomized patients.

*Study information is displayed as described in protocol V2.0. Sites must always adhere to the currently approved local version, therefore some information may differ locally.

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