Breast cancer ER+/HER2- early breast cancer
Conditions
Interventions
None listed
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-I CSP (D8531C00002) and summarised below. Specimen Inclusion criteria: All patients in this study must provide an archival FFPE tumour tissue sample. If the patient has not received any neoadjuvant treatment, a tumour sample collected during definitive surgery is preferable (although tumour sample collected during initial diagnostic workup will be accepted). If the patient has received neoadjuvant treatment, then a tumour sample collected during initial diagnostic workup is required. At least 200 viable tumour cells in invasive tumour component of the FFPE sample. FFPE tissue specimen cut into sections of 4-5 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. Specimens prepared using fixatives and/or fixation times other than 6 to 72 hours in 10% Neutral Buffered Formalin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical utility of the Ki-67 IHC MIB-1 pharmDx (Dako Omnis) will be evaluated if the D8530C0002 clinical study confirms clinically relevant efficacy and meets its primary endpoint (outlined in the D8531C00002 CSP, Section 9.4.2). Clinical evidence for the Ki-67 assay will be evaluated through subgroup analysis of the primary endpoint based on tumour expression of Ki-67 as measured by Ki-67 IHC MIB-1 pharmDx (Dako Omnis) in all tested samples. Clinical performance of the device will be established if patients with tumours that have Ki-67 > 20% have at least similar efficacy profiles as compared to the overall study population. | — |
Countries
Netherlands
Outcome results
None listed