Clinical Trials

JBCRG-TR03 (OncotypeDX)
GLOBAL OncotypeDX(JBCRG-TR03)

Study on "recurrence score" of prognostic factors in Japanese patients with early stage breast cancer

State
Completed

Objectives
For the primary analysis, patients will be characterized prospectively by their Recurrence Score as low risk, intermediate risk, or high risk, and a hypothesis test will be performed to demonstrate that the risk of distant recurrence for patients in the low risk group is significantly lower than that of patients in the high risk group.

Subjects
Patients who received either Tamoxifen or another LHRH agonists between the years 1993-1998, Patients who have a formalin fixed paraffin embedded tissues (FPET) sample available from the Pathology archive, Clinically eligible with follow-up data available, Patients should be considered Estrogen Receptor Positive.

First and final H&E stained slide and six μm sections of FPET tissues on unstained slides.

Endpoints
RT-PCR analysis of tissue samples will be conducted using 16 cancer-related genes and 5 reference genes. Genomic Health,Inc. will extract RNA and perform molecular assays of quantitive gene expression using TaqMan RT-PCR assays. The TaqMan assay will be used to analyze the expression levels of the 16 cancer-related genes and 5 reference genes in the RNA extracted from the fixed paraffin embedded tumor samples. RT-PCR will be performed in triplicate with RNA input at 2 ng per reaction.

Trial Period
April 2007 -

Lead Principal Investigator
Masakazu Toi (Department of Surgery, Breast Surgery, Graduate School of Kyoto University)

Target Sample Size
250

Regimen

Source of Funding
Genomic Health, Inc. Japan Breast Cancer Research Group (JBCRG)

Conference Presentation
The first report of the association between the recurrence score and risk of recurrence in Japanese population (JBCRG-TR03)

Articles and Publications
Economic evaluation of the 21-gene signature (Oncotype DX(®)) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03). Clinical Significance of the 21-Gene Signature (Oncotype DX) in Hormone Receptor-Positive Early Stage Primary Breast Cancer in the Japanese Population

UMIN-ID

jRCT

Memo

COI Disclosure

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