CTRI/2022/01/039209招募中4 期
A MULTI-COUNTRY OBSERVATIONALRETROSPECTIVE STUDY TO EVALUATE THEPREVALENCE OF PD-L1 AND ITS ROLE INPATIENTS WITH TNBC TREATED WITH SYSTEMICTHERAPY (VANESSA)
F HoffmanLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Patient cases must meet the following criteria for study entry
- •Ã¯â??· Signed Informed Consent Form if and as required according to local laws and
- •regulations
- •Ã¯â??· Aged more than or equal to 18 years at the time of diagnosis
- •Ã¯â??· 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.
- •Ã¯â??· 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
- •Ã¯â??· 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
- •Ã¯â??· Documentation of tissue source primary breast cancer, de novo breast cancer
- •metastatic tumor location biopsy or resection tissue size and tumor content
- •Ã¯â??· 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
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Ã¯â??· No available archival tumor tissue for PD-L1 testing
- •Ã¯â??· Tissue samples of poor quality based on total and viable tumor content and/or bad
- •Ã¯â??· Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases,
- •and lavage samples are not acceptable
- •Ã¯â??· Patients whose tumor tissue is not evaluable for local and central testing
研究者
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