Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897845
• Other study ID #: CDR0000598872
• Secondary ID: ECOG-E2197B-ICSC
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 16, 2017
• Start date: June 17, 2008
• Est. completion date: December 2, 2013

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor samples from women who have undergone chemotherapy for breast cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2541
• Est. completion date: December 2, 2013
• Est. primary completion date: December 2, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• RNA analysis

• microarray analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of results with Outcome		1 month