Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ

ECOG-ACRIN Cancer Research Group

Status: Completed

Conditions: Breast Cancer

Treatments: Genetic: RNA analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: laboratory biomarker analysis; Genetic: gene expression analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01132560

CDR0000671157

ECOG-E5194T1

Details and patient eligibility

About

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 studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.

Full description

OBJECTIVES:

• To validate the prognostic utility of a new ductal breast carcinoma in situ (DCIS) genomic score and the Oncotype DX Recurrence Score® assay in tissue samples from patients with DCIS enrolled on clinical trial ECOG-E5194.

OUTLINE: RNA extracted from archived tissue samples are analyzed for gene expression profile by Oncotype DX Recurrence Score® assay (a reverse transcriptase-PCR-based assay).

Enrollment: 500 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of ductal breast carcinoma in situ

• Enrolled on clinical trial ECOG-E5194

  • Local surgery without radiotherapy
  • Treated or not treated with tamoxifen

• Available tissue samples

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics