Triple-negative Breast Cancer: a New Perspective on Biomarkers

NCT03539965 | Completed

• 1 other identifier: TNBCbrazil
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Triple Negative Breast Neoplasms; Triple Negative Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  The first event defined as local recurrence or distant relapse, or death, whichever come first.

  Approximately 24 months: from diagnosis up to the first event defined as local recurrence or distant relapse, or death, whichever come first through study completion.

Secondary Outcomes (4)

• Clinical Response Rate

  From date of first cycle of chemotherapy until completion of neoadjuvant treatment, approximately 16 weeks

• Objective response rate

  From date of first cycle of chemotherapy until completion of neoadjuvant treatment, approximately 16 weeks

• Determine predictive markers

  Approximately 24 weeks: from diagnosis up to surgery.

• Determine prognostic markers

  Approximately 24 months: from diagnosis up to the first event defined as local recurrence or distant relapse, or death, whichever come first through study completion.

Study Arms (1)

Single-arm cohort

Initially, patients will be analyzed in a single group. After determining the status of the biomarkers, the patient sample will be divided into specific groups for comparative purposes.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who is biopsied and diagnosed with breast cancer in the public health system is referred to Brazilian National Cancer Institute (INCA) through a registry and screening performed by the Municipal Health Department of the city of Rio de Janeiro. Therefore, it becomes a great field for research of cancer patients by the large number of cases. Absolutely all patients enrolled in INCA for treatment have their biopsy material reviewed in DIPAT. In this cohort, will be studied women with locally advanced TNBC consecutively enrolled at INCA between January 2010 and December 2014 that were submitted to neoadjuvant chemotherapy and subsequently operated.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Instituto Nacional do Cancer - CPQ

Rio de Janeiro, 20231050, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffin-embedded Hematoxylin \& Eosin (H \& E) core biopsy/early biopsy and surgical specimens previously analyzed in the Department of Patology of the Brazilian National Cancer Institute (INCA) will be doubly reviewed by two pathologists in our study for histological grade (Scarff-Bloom-Richardson method, modified by Elston and Ellis), histological type (according to World Health Organization, 2012), presence of carcinoma component "in situ", angiolymphatic invasion, perineural infiltration, presence of lymphocytic inflammatory infiltrate.

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jesse L da Silva, MD

  Instituto Nacional de Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 30, 2018
• Study Start: January 1, 2010
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)