Studying Tumor Tissue Samples From Patients With Early-Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

Correlation of Oncotype Dx With Image Features and Molecular Characteristics of Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00899639
• Other study ID #: 000809
• Secondary ID: P30CA072720CDR00
• Status: Withdrawn
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 27, 2015
• Start date: May 2008
• Est. completion date: May 2008

Study information

• Verified date: May 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• 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 tissue samples from patients with early-stage breast cancer.

Description:

OBJECTIVES:

• To characterize differences in tumor morphology and molecular features that exist in good- and poor-prognosis breast cancer as determined by Oncotype Dx assay (a reverse transcriptase-PCR-based assay).

• To develop a computer-aided design (CAD)-based system of analysis of digitized histological images that would perform as well as Oncotype Dx assay in stratifying estrogen receptor-positive (ER+) breast cancer into prognostic categories.

• To identify new therapeutic targets in the PI3-kinase signaling pathway for a subset of poor-prognosis ER+ breast cancers.

OUTLINE: Patients who had Oncotype Dx assay (a reverse transcriptase-PCR-based assay) performed for their breast cancer are identified by review of medical records. Diagnostic H&E stained tumor tissue samples are reviewed by a pathologist. Relevant pathologic features of the tumor (size, stage, grade, estrogen receptor, progesterone receptor, and HER2 staining) and linked Oncotype Dx score are recorded.

The H&E stained tumor tissue samples are scanned to create high-resolution digital images. The images from each tissue sample are subjected to image analysis algorithms to identify sets of image features that most clearly separate tumors with low recurrence scores from those with high recurrence scores.

Unstained paraffin sections from each tumor tissue sample, when available, are processed using IHC to analyze PI3-kinase signaling pathway (PTEN expression). Staining for other components of the PI3-kinase signaling pathway, phospo-AKT, and other proteins of interest is also performed. DNA is extracted from the samples and subjected to pyrosequencing analysis on exons 9 and 20 of PI3KCA. Sequencing of other relevant potential oncogenes, such as AKT, is also performed. Statistical analysis is performed to look for a correlation between Oncotype Dx scores and the presence of PI3KCA mutations and/or loss of PTEN expression.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of early-stage breast cancer for which an Oncotype Dx assay has been performed

• Must have diagnostic H&E stained tumor tissue samples available

• Hormone receptor status:

• Estrogen receptor-positive tumor

PATIENT CHARACTERISTICS:

• Menopausal status not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in tumor morphology and molecular features that exist in good- and poor-prognosis breast cancer as determined by Oncotype Dx assay			No
Primary	Histological image-based analysis in stratifying estrogen receptor-positive breast cancer into prognostic categories			No
Primary	Identification of new therapeutic targets in the PI3-kinase signaling pathway for a subset of poor-prognosis estrogen receptor-positive breast cancers			No