Triple Negative Breast Cancer Clinical Trial
Official title:
Triple-negative Breast Cancer: a New Perspective on Predictive and Prognostic Biomarkers
A single-institutional cohort to determine the prevalence of new immunohistochemical panel in advanced triple-negative submitted to neoadjuvant chemotherapy and its association with response and survival.
Background/Rationale: Triple negative breast cancer (TNBC) is known to be a heterogeneous
disease, and different molecular sub-classifications are proposed based in specific
biomarkers as immunohistochemical (IHC) expression of the androgen-receptor (AR), Epidermal
growth Factor Receptor (EGFR), Cytokeratin 5/6 (CK5/6), Cytokeratin14 (CK14), Cytokeratin 17
(CK17), clusters of differentiation 117 (CD 117), p53, Ki67 level, Programmed cell
death-ligand 1 (PD-L1) and PD-L2 in tumor cell membrane and the pattern of tumor infiltrating
mono-lymphocytes (PD-1+, FOXP3+, CD 4+ or cluster designation 8 (CD8 +), CD 3+, cluster of
differentiation 56 (CD56+), cluster designation 68 (CD68+) or CD 14+). Predicting response
and survival to neoadjuvant treatment of locally advanced triple-negative breast cancer
remains a major challenge. Many doubts still prevail over the role of new biomarkers in
predicting different outcomes for tumors with the same stage and morphological
characteristics.
Objectives and Hypotheses:
Primary objective: To evaluate the association of the intratumoral lymphocytic infiltrate
(TILs) status profile in the core biopsy with complete pathological response (CPR) outcomes
to neoadjuvant chemotherapy and progression-free survival (PFS). Secondary objectives: To
evaluate the association of the others biomarkers expression profile and the quality of TILs
with PFS and CPR. To determine the prevalence of a large immunohistochemical panel (AR, EGFR,
CK5/6, CK14, CK17, CD 117, p53, Ki67 level, PD-L1 and PD-L2 in tumor cell membrane and the
pattern of tumor infiltrating mono-lymphocytes PD-1+, FOXP3+, CD 4+ , CD8 +, CD 3+, CD56+,
CD68+ and/or CD 14+), before and after neoadjuvant chemotherapy. To determine if the
negativation of biomarkers after the systemic treatment is associated with CPR and PFS.
Methods:
Study design: A cohort with retrospective data collection and sectional analysis of
pathological material.
Data Source(s): Medical records and pathological material. Study Population: Women with
locally advanced triple negative breast cancer consecutively enrolled at Brazilian National
Cancer Institute (INCA) submitted to neoadjuvant treatment and subsequently operated.
Exposure(s): Status of specified biomarkers. Outcome(s): Complete Pathologic Response and
Progression free Survival and Sample Size Estimations: With a type I error of 5% and study
power of 80%, it is estimated that 155 patients are needed.
Statistical Analysis: Statistical analysis will be performed using SPSS (version 18.0 for
windows, statistical package for social science (SPSS) Inc., Chicago, IL). Survival curves
will be constructed using the Kaplan-Meier method.
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