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PD-L1 Expression in Chinese Patients with Early-stage Triple-negative Breast Cancer: A Multi-center Retrospective Observational Study

PD-L1 Expression in Chinese Patients with Early-stage Triple-negative Breast Cancer: A Multi-center Retrospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077286
Enrollment
Unknown
Registered
2023-11-03
Start date
2023-11-10
Completion date
Unknown
Last updated
2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early stage triple negative breast cancer

Interventions

Triple-negative Breast Cancer Patients:NA

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Female Chinese patient =18 years old at time of early stage TNBC diagnosis; 2) Patient must have a histologically documented diagnosis of either T1c N1-2 or T2-4 N0-2*(stage IIA~IIIB) TNBC (histologically documented ER-, PR- and HER2-); 3) Patient has a biopsy or surgical resection sample from a newly obtained or an archival tissue block of maximum three years old available for PD-L1 testing?; 4) No prior systemic therapy including but not limited to chemotherapy, immunotherapy, target therapy for early TNBC before sample material collection; 5) Patients must have informed consent form (ICF) signed for any future study or have conditions that are accepted by IRB/ERC to waive ICF or are willing to sign the informed consent form. * per AJCC for breast cancer staging criteria version 8 ? Newly-obtained specimen(collected up to 90 days prior to start of PD-L1 IHC test) is preferred to archived one

Exclusion criteria

Exclusion criteria: 1) Patient has only a specimen obtained with fine needle aspirate (FNA) or cytologic specimen

Design outcomes

Primary

MeasureTime frame
PD-L1 protein expression;

Secondary

MeasureTime frame
Association between PD-L1 expression and demographic and clinicopathological features;

Countries

China

Contacts

Public ContactBu Hong

West China Hospital of Sichuan University

hongbu@scu.edu.cn+86 189 8060 1026

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026