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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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Recurrence-free interval

Safety Issue:

No

Principal Investigator

Brian Leyland-Jones, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Winship Cancer Institute of Emory University

Authority:

Unspecified

Study ID:

CDR0000598872

NCT ID:

NCT00897845

Start Date:

January 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

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