Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast
Conditions
Interventions
None listed
Sponsors
F HoffmanLa Roche Ltd
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient cases must meet the following criteria for study entry ? Signed Informed Consent Form if and as required according to local laws and regulations ? Aged more than or equal to 18 years at the time of diagnosis ? 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) ? 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 ? 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 ? Documentation of tissue source primary breast cancer, de novo breast cancer metastatic tumor location biopsy or resection tissue size and tumor content ? 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: ? No available archival tumor tissue for PD-L1 testing ? Tissue samples of poor quality based on total and viable tumor content and/or bad fixation ? Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable ? Patients whose tumor tissue is not evaluable for local and central testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the prevalence of PD-L1 positivity in 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 eTNBC and mTNBC patients treated with systemic therapy.Timepoint: -PD-L1 status in eTNBC and mTNBC patients -TNBC initial diagnosis -The primary endpoint is OS, and the secondary endpoints are 12- and 18-month OS rates, PFS, ORR (RECIST v1.1), duration of response, clinical benefit rate, patient reported outcomes (PROs), and safety. Exploratory endpoints include further PROs, pharmacokinetics, and translational research. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the inter-observer concordance on PD-L1 positivity using the Ventana PD-L1 (SP142) assay between local and central laboratories. The pathologists assessing the PD-L1 positivity will be appropriately trained in the use of this assay. Timepoint: - Inter-observer concordance on PD-L1 status in eTNBC and mTNBC patients. (PD-L1 status determined in Local and Central laboratory) - Data required for the primary and secondary endpoints will also be obtained from PD-L1 expression testing of archived tissue samples from all patients using the Ventana PD-L1 (SP142) assay - locally and centrally. | — |
Countries
Algeria, Chile, Finland, Germany, India, Italy, Kenya, Lebanon, Lithuania, Morocco, Peru, Russian Federation, Saudi Arabia, Serbia, South Africa, Tunisia, Turkey, United Kingdom, Viet Nam
Contacts
Public ContactManjula Ujagiri
Roche Products (India) Pvt Ltd
Outcome results
None listed