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

NCT00899639 | Withdrawn DMC

• 4 other identifiers: 000809P30CA072720CDR0000600231CINJ-0220080120
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; estrogen receptor-positive breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (3)

• Differences in tumor morphology and molecular features that exist in good- and poor-prognosis breast cancer as determined by Oncotype Dx assay

• Histological image-based analysis in stratifying estrogen receptor-positive breast cancer into prognostic categories

• Identification of new therapeutic targets in the PI3-kinase signaling pathway for a subset of poor-prognosis estrogen receptor-positive breast cancers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ER+ breast cancer with associated Oncotype Dx scores

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shridar Ganesan, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: May 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 29, 2015

Record last verified: 2015-05