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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04403984
• Other study ID #: HE10A13
• Status: Active, not recruiting
• Start date: April 24, 2013
• Est. completion date: March 2023

Study information

• Verified date: March 2023
• Source: Hellenic Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: March 2023
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Greece	George Fountzilas	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Cooperative Oncology Group

Country where clinical trial is conducted

Greece, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		From treatment initiation to the first documented disease progression, up to 5 years
Primary	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.