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

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT04403984
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

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.

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 Timeline

• Study Start: 2013-04-24
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Primary Completion: 2020-12-21
• Status Verified: 2023-03
• Study Completion: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 750

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

George Fountzilas; 🇬🇷 Athens, Greece