A RETROSPECTIVE DATA ANALYSIS STUDY TO EVALUATE THE PREVALENCE OF PD-L1 TESTING IN TNBC PATIENTS
- Conditions
- Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast
- Registration Number
- CTRI/2022/01/039209
- Lead Sponsor
- F HoffmanLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patient cases must meet the following criteria for study entry
ïâ??· Signed Informed Consent Form if and as required according to local laws and
regulations
ïâ??· Aged more than or equal to 18 years at the time of diagnosis
ïâ??· 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)
ïâ??· 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
ïâ??· 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
ïâ??· Documentation of tissue source primary breast cancer, de novo breast cancer
metastatic tumor location biopsy or resection tissue size and tumor content
ïâ??· 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
Patients who meet any of the following criteria will be excluded from study entry:
ïâ??· No available archival tumor tissue for PD-L1 testing
ïâ??· Tissue samples of poor quality based on total and viable tumor content and/or bad
fixation
ïâ??· Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases,
and lavage samples are not acceptable
ïâ??· Patients whose tumor tissue is not evaluable for local and central testing
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the prevalence of PD-L1 positivity in primary or metastatic tissue <br/ ><br>(defined by expression on tumor-infiltrating immune cells covering � 1% of tumor <br/ ><br>area by IHC using the Ventana PD-L1 [SP142] assay, as determined in the local <br/ ><br>laboratory) among eTNBC and mTNBC patients treated with systemic therapy.Timepoint: -PD-L1 status in eTNBC and mTNBC patients <br/ ><br>-TNBC initial diagnosis <br/ ><br>-The primary endpoint is OS, and the secondary endpoints are 12- and 18-month OS <br/ ><br>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 Outcome Measures
Name Time Method To evaluate the inter-observer concordance on PD-L1 positivity using the Ventana <br/ ><br>PD-L1 (SP142) assay between local and central laboratories. The pathologists <br/ ><br>assessing the PD-L1 positivity will be appropriately trained in the use of this assay. <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: - Inter-observer concordance on PD-L1 status in eTNBC and mTNBC patients. <br/ ><br>(PD-L1 status determined in Local and Central laboratory) <br/ ><br>- 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 <br/ ><br>(SP142) assay - locally and centrally. <br/ ><br> <br/ ><br>