Clinical Performance Study Plan for Ki-67 IHC MIB-1 pharmDx (Dako Omnis) on Early Breast Cancer Specimens used to identify subjects for enrolment in AstraZeneca*s Phase III CAMBRIA-1 trial (D8531C00002)
- Conditions
- Breast cancerER+/HER2- early breast cancer10006232
- Registration Number
- NL-OMON56528
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 42
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
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.
Specimen 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method