S9313A Protein Expression Analysis of Breast Cancer Tissue Microarrays From Clinical Trial SWOG-9313

NCT00896727 | Completed

• 3 other identifiers: CDR0000467801SWOG-S9313-INT-0137-ICSCNCI-2009-00806
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Studying the proteins expressed in tumor tissue samples in the laboratory from patients with cancer may help doctors learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment. PURPOSE: This laboratory study is looking at protein expression in predicting response to treatment using tumor tissue samples from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.

Conditions

Breast Cancer

Keywords

stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (2)

• In-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 as measured by automated quantitative analysis (AQUA™)

  at baseline

  Retrospectively at baseline

• Main effects of ER, PR, HER-2, and p53, as well as interactions to generate classes formed by clustering of biomarkers, on a large breast cancer tissue microarray to predict disease-free and overall survival

  at baseline

  Retrospectively at baseline

Interventions

gene expression analysis GENETIC

protein expression analysis GENETIC

fluorescent antibody technique OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from SWOG 9313 consented to banking

DISEASE CHARACTERISTICS: * Diagnosis of primary invasive adenocarcinoma of the breast * Stage I-IIIA disease (T1-3, N0-1, M0) * Enrolled on clinical trial SWOG-9313 * Tumor tissue available for testing PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gene Expression Profiling; Fluorescent Antibody Technique

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Immunohistochemistry; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques

Study Officials

• David Rimm, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: July 17, 2006
• Primary Completion: January 2, 2009
• Study Completion: April 2, 2009
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

US (1)