The study population is intended to follow the real-world use of systemic therapy. Eligible patients with either eTNBC or mTNBC will be enrolled consecutively
Conditions
Interventions
Non-interventional study
Sponsors
F. HOFFMANN-LA ROCHE LTD
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patient cases must meet the following criteria for study entry: 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 (Allison et al. 2020; Wolff et al. 2018; Wolff et al. 2013) 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 (see 8.1.1 for detailed requirements) 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 that received any systemic therapy in early-stage disease and/or in metastatic setting 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: Patients who meet any of the following criteria will be excluded from study entry: 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 |
|---|---|
| Name: This study will evaluate the prevalence of PD-L1 positivity rates in tumors from patients with TNBC.;Timepoints: End of the sudy ;Measure: To evaluate the prevalence of PD-L1 positivity on primary or metastatic tissue (defined by expression on tumor- infiltrating immune cells covering = 1% of tumor area by IHC using the Ventana PD-L1 [SP142] assay, as determined in the local laboratory) among early TNBC (eTNBC) and metastatic TNBC (mTNBC) patients treated with systemic therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: To evaluate the inter-observer concordance on PD-L1 positivity using the Ventana PD-L1 (SP142) assay between local and central laboratories.;Timepoints: End of study ;Measure: To evaluate the inter-observer concordance on PD-L1 positivity using the Ventana PD-L1 (SP142) assay between local and central laboratories.;Name: Patient demographic and clinicopathologic characteristics as available and described at the time of diagnosis, by PD- L1 status (positive/negative) ;Timepoints: End of study ;Measure: Patient demographic and clinicopathologic characteristics as available and described at the time of diagnosis, by PD- L1 status (positive/negative) ;Name: Treatment choices in the neoadjuvant, adjuvant and metastatic setting ;Timepoints: End of study ;Measure: Treatment choices in the neoadjuvant, adjuvant and metastatic setting ;Name: PD-L1 positivity rates in core biopsy and surgical samples in patients treated with or without neoadjuvant chemotherapy (paired samples where available) ;Timepoints: End of study ;Measure: PD-L1 positivity rates in core biopsy and surgical samples in patients treated with or without neoadjuvant chemotherapy (paired samples where available) ;Name: PD-L1 positivity rates among metastatic sites and primary tumor (paired samples where available) ;Timepoints: End of study ;Measure: PD-L1 positivity rates among metastatic sites and primary tumor (paired samples where available) ;Name: tpCR in eTNBC patients after neoadjuvant chemotherapy, by PD-L1 status (positive/negative). The tpCR is defined as the eradication of invasive disease in the breast and lymph nodes irrespective of ductal carcinoma in situ ;Timepoints: End of study ;Measure: tpCR in eTNBC patients after neoadjuvant chemotherapy, by PD-L1 status (positive/negative). The tpCR is defined as the eradication of invasive disease in the breast and lymph nodes irrespective of ductal carcinoma in situ ;Name: iDFS in eTNBC patients by PD-L1 status (positive/ | — |
Countries
Algeria, Chile, Finland, Germany, India, Italy, Kenya, Latvia, Lithuania, Morocco, Peru, Republic of Korea, Republic of Serbia, Saudi Arabia, South Africa, Tunisia, Turkey, United Kingdom, Viet Nam
Outcome results
None listed