Molecular Profiling of E2197 FFPE Samples Using a Custom 512 Breast Cancer Gene Set on the DASL Platform: Towards the Development of Predictive Gene Sets for Risk of Recurrence in Patients With Operable Breast Cancer Treated With Adjuvant Therapy
Data Collection
Collected from past medical records and data - RetrospectiveBreast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: June 17, 2008
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * To identify gene sets for risk of recurrence using molecular profiling in samples from women with lymph node-positive or high-risk lymph node-negative breast cancer on clinical trial ECOG-E2197. Secondary * To define a set of significant genes as prognostic markers of recurrence. * To compare the prognostic value of the Oncotype DX™ (ODX) 21 gene assay of clinical trial with gene sets determined in this study. * To compare the DASL™ assay of the ODX 21 genes with ODX assay results of clinical trial. * To compare the prognostic value of selected genes with gene sets determined in this study. OUTLINE: This is a multicenter study. Samples are used in molecular profiling by applying a custom panel of breast cancer-related genes to a cDNA-mediated Annealing, Selection, Extension, and Ligation (DASL™) assay, immunohistochemistry, and other studies.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2541 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer tumor samples collected on clinical trial ECOG-E2197 * Histologically lymph node-positive (N1-3) OR high-risk lymph node-negative disease * Hormone receptor-positive or negative disease (status known) * HER2 status known PATIENT CHARACTERISTICS: * Menopausal status not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives