Breast cancer ER+/HER2- early breast cancer
Conditions
Interventions
 
NA 
Sponsors
Astra Zeneca
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Sample requirements for testing from patients with ER+/HER2- early breast cancer and who have completed definitive locoregional therapy and at least 2 years of standard adjuvant endocrine-based therapy without disease recurrence. Please note, overall patient inclusion/exclusion criteria for this study are documented in Section 5.1 of the CAMBRIA-1 CSP (D8531C00002) Specimen Inclusion criteria: Only some patients will be asked to consent to submit their samples for Ki67 central assessment. Treatment naïve FFPE tumour samples should be submitted prior to enrolment with enough time for sample evaluation to be performed within the clinical study enrolment window. Sample requirements include: -At least 200 viable tumour cells in invasive tumour component of the FFPE sample. -FFPE tissue specimen cut into sections of 4- to 5 µm and stained within 4 months of sectioning and stored at room temperature.
Exclusion criteria
Exclusion criteria: Specimen Exclusion criteria: Bone biopsies, fine needle aspirates, cell pellets, or cytology samples
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical utility of the Ki-67 REDACTED will be evaluated if the D8530C0002 clinical study confirms clinically relevant efficacy and meets its primary endpoint. As outlined in the D8531C00002 CSP, Section 9.4.2, the analysis for the primary endpoint of invasive breast cancer-free survival (IBCFS) of the CAMBRIA-1 clinical study will include all randomised patients as randomised, regardless of whether the patient withdraws from randomised study treatment or receives another anti-cancer therapy. The analysis will be conducted using a stratified log-rank test adjusting for stratification factors. The Kaplan-Meier method will be used to estimate IBCFS rates over time by treatment. The stratified Cox proportional hazards model will be used to assess the hazard ratio between the treatment arms. The efficacy of camizestrant will be described by the estimated hazard ratio together with its REDACTED confidence interval (CI) and appropriate CI (according to the significance level in the multiple testing procedures [MTP]) and p value will be presented (a hazard ratio less than 1 will favour camizestrant). For the performance study, an analysis in the patients who required REDACTED as an eligibility criterion (as described in Section 22 of the Clinical performance study plan [CPSP]) will be performed using a stratified Cox proportional hazards model (same methodology as for the primary endpoint for the CAMBRIA-1 clinical study). This would support the objective of the CPSP to determine whether REDACTED identified by the Ki-67 REDACTED assay can be used as one of the risk criteria (alongside tumour size, grade, lymph node status, and genomic signature) for identifying patients with the intermediate to high-risk status that may benefit from camizestrant. Further detail will be added in the main statistical analysis plan. | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Turkey, United States
Contacts
Public ContactLaura Taylor
Astra Zeneca
Outcome results
None listed