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

ECOG-ACRIN Cancer Research Group500 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Breast Cancer

Interventions

RNA analysisGENETIC

gene expression analysisGENETIC

reverse transcriptase-polymerase chain reactionGENETIC

laboratory biomarker analysisOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Ipsilateral local failure (first event of invasive or DCIS recurrence)

Time frame: 1 month

Secondary Outcomes

Contralateral breast cancer (invasive or DCIS)

Time frame: 1 month

Data from ClinicalTrials.gov

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