Triple-negative breast cancer treated with systemic therapy Cancer Malignant neoplasm of breast
Conditions
Interventions
Approximately 2,700 patients with a new diagnosis of eTNBC or mTNBC between 1st January 2014 and 31st December 2017 will be considered for inclusion in this study. Medical/treatment history data will
Sponsors
Roche (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form, if and as required, according to local laws and regulations 2. Aged =18 years at the time of diagnosis 3. Histologically documented TNBC, assessed locally and defined as ER and PR positivity of less than 1% and HER2 IHC0, IHC1+, or IHC2+/ISH-, as determined according to ASCO/CAP guidelines 4. New diagnosis of eTNBC (early or locoregionally advanced TNBC, amenable to treatment with curative intent) or mTNBC (metastatic or locoregionally advanced unresectable TNBC, not amenable to treatment with curative intent) between 1st January 2014 and 31st December 2017 5. Available formalin-fixed paraffin-embedded (FFPE) tumor tissue of good quality based on total and viable tumor content for local and central laboratory PD-L1 testing 6. Documentation of tissue source (primary breast cancer, de novo breast cancer, metastatic tumor location), biopsy or resection, tissue size and tumor content 7. Patients who received any systemic therapy in early-stage disease and/or in metastatic setting 8. Only patients with documented, locally determined PD-L1 status using Ventana PD-L1 (SP142) assay by trained pathologists, will be eligible for central testing and their data will be included in the study analysis
Exclusion criteria
Exclusion criteria: 1. No available archival tumor tissue for PD-L1 testing 2. Tissue samples of poor quality based on total and viable tumor content and/or bad fixation 3. Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable 4. Patients whose tumor tissue is not evaluable for local and central testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PD-L1 positivity, as defined by expression on tumor-infiltrating immune cells covering =1% of tumor area by IHC using the Ventana PD-L1 (SP142) assay, measured at a single timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Inter-observer concordance on PD-L1 positivity using the Ventana PD-L1 (SP142) assay between local and central laboratories, measured at a single timepoint | — |
Countries
Algeria, Chile, England, Finland, Germany, India, Italy, Kenya, Korea, South, Latvia, Lebanon, Lithuania, Morocco, Peru, Russian Federation, Saudi Arabia, Serbia, South Africa, Tunisia, Turkey, United Kingdom, Viet Nam
Contacts
Public ContactTrial Information Support Line
Outcome results
None listed