Triple-negative Breast Cancer: a New Perspective on Biomarkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Triple Negative Breast Neoplasms Triple Negative Breast Cancer

Keywords

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Neoadjuvant Chemotherapy Predictive Biomarkers Prognostic Biomarkers Complete Pathological Response Tumor Infiltrating Lymphocytes PD-L1 PD-L2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single-arm cohort

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No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women older than 18 years
* Locally advanced TNBC (T3-4, any Node, M0; any Tumor, N1-3, M0)
* Patients submitted to anthracycline and taxane-based neoadjuvant chemotherapy and then operated between January 2010 and December 2014 at the Brazilian National Cancer Institute.

Exclusion Criteria

* Patients with metastatic Breast Cancer;
* Other non-epithelial histologies of breast cancer;
* Pure Ductal Carcinoma In Situ diagnoses are not eligible.
* Patients with scarce material for immunohistochemistry;
* Other primary synchronous or anachronistic tumors in the breast or other sites;
* No prior immunotherapeutic, chemotherapeutic or antiandrogenic drugs allowed
* Patients treated with alternative neoadjuvant chemotherapy regimens (not based on anthracycline and taxane) or with only hormone therapy;
* Patients who received chemotherapy or who were operated outside the INCA.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Jesse Lopes da Silva

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesse L da Silva, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancer

Locations

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Instituto Nacional do Cancer - CPQ

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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TNBCbrazil

Identifier Type: -

Identifier Source: org_study_id