Clinical trial NCT04403984: Investigation of Genomic Alteration in Patients With Luminal A or Luminal B Subtypes
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Early breast cancer
Luminal A breast cancer
Luminal B breast cancer
Operated breast cancer
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Progression free survival
timeFrame: From treatment initiation to the first documented disease progression, up to 5 years
measure: Overall survival
timeFrame: From date of treatment initiation until death from any cause or date of last contact whichever occurred first, assessed up to 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: George Fountzilas
Study officials:
affiliation: Hellenic Cooperative Oncology Group
name: George Fountzilas, MD
role: PRINCIPAL_INVESTIGATOR
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