Clinical trial NCT00899639: Studying Tumor Tissue Samples From Patients With Early-Stage Breast Cancer
Official title: Correlation of Oncotype Dx With Image Features and Molecular Characteristics of Breast Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
estrogen receptor-positive breast cancer
male breast cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2009-05-12
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ER+ breast cancer with associated Oncotype Dx scores

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in tumor morphology and molecular features that exist in good- and poor-prognosis breast cancer as determined by Oncotype Dx assay
measure: Histological image-based analysis in stratifying estrogen receptor-positive breast cancer into prognostic categories
measure: Identification of new therapeutic targets in the PI3-kinase signaling pathway for a subset of poor-prognosis estrogen receptor-positive breast cancers
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Shridar Ganesan, MD
role: PRINCIPAL_INVESTIGATOR
References: