Investigation of Genomic Alteration in Patients With Luminal A or Luminal B Subtypes

January 13, 2023 updated by: Hellenic Cooperative Oncology Group

Investigation of the Prognostic Value of Genomic Alterations or Protein Expression in Patients With Operated Early Breast Cancer of Luminal A or Luminal B Subtypes

This is a translational study in patients with operated early breast cancer of Luminal A or Luminal B sub types.The Hellenic Cooperative Oncology Group (HeCOG) has designed an observational biomarker-driven study in patients with Luminal A or Luminal B breast cancer, with the aim to collect valuable biological material from these patients and investigate biomarkers with potential prognostic value.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The HE10A/13 study is an observational study of the Hellenic Cooperative Oncology Group (HeCOG). Its main purpose is the collection of biological material from patients in search of prognostic / predictive biomarkers. Each patient signed an informed consent for the provision of biologic material for future research purposes. The study was conducted in accordance with the Declaration of Helsinki. The clinical and translational protocol has been approved by the Hellenic Cooperative Oncology Group Scientific Committee and is under review by the Institutional Review Board of Metropolitan Hospital. Patients exclusively with Luminal A or Luminal B (Estrogen Receptors (ER)-positive with or without Progesterone Receptors (PgR) positive, HER-negative) breast cancer who received adjuvant chemotherapy with positive lymph nodes or node-negative with tumor stage or pathological features according to Saint Gallen guidelines suggesting high-risk or when genomic testing determined in favor of adjuvant chemotherapy are eligible for registration in the study.

Before registration to the study, each patient signed an informed consent for the provision of biologic material for research purposes.

Potential biomarkers will be examined using in situ or molecular methods in Formalin fixed paraffin embedded (FFPE) tumor sections. For tumor subtyping immunohistochemistry for ER, PgR, HER2, Ki67 and Fluorescence in Situ Hybridization (FISH) will be performed where needed for the assessment of HER2 status; for Epidermal Growth Factor Receptor (EGFR) and CK5 for the classification of basal-like tumors; and, the expression of CD8, CD3 and FOXP3 on (Tumor- infiltrating Lymphocytes (TILs) will also be evaluated. Moreover, will be evaluated the mutational profile, including actionable genomic alterations, and the immune response -related profile of Greek women with breast cancer, via the application of DNA/RNA Next Generation Sequencing (NGS) technologies, relative also to patient outcome.

Study Type

Observational

Enrollment (Actual)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Athens, Greece
        • George Fountzilas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This is a retrospective analysis of patients with operative early breast cancer of Luminal A and Luminal B sub types. Patients have been treated in Hellenic Cooperative Oncology Group (HeCOG) - affiliated departments of Oncology.

Description

Inclusion Criteria:

  • 18 years old or older
  • Luminal A breast cancer sub type
  • Luminal B breast cancer sub type
  • Positive lymph nodes
  • Node- negative with tumor stage or pathological features according to Saint Gallen guidelines.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Patients with Luminal A breast cancer
Patients confirmed with Luminal A breast cancer sub type
Patients with Luminal B breast cancer
Patients confirmed with Luminal B breast cancer sub type

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: From treatment initiation to the first documented disease progression, up to 5 years
From treatment initiation to the first documented disease progression, up to 5 years
Overall survival
Time Frame: From date of treatment initiation until death from any cause or date of last contact whichever occurred first, assessed up to 5 years.
From date of treatment initiation until death from any cause or date of last contact whichever occurred first, assessed up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: George Fountzilas, MD, Hellenic Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2013

Primary Completion (Actual)

December 21, 2020

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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