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
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: gene expression analysis Type: Genetic
Name: protein expression analysis Type: Genetic
Name: fluorescent antibody technique Type: Other
Name: laboratory biomarker analysis Type: Other
Overall Status
Recruiting
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.
Detailed Description
OBJECTIVES:

- Assess in-situ protein expression of estrogen receptor (ER), progesterone receptor (PR), HER-2, and p53 by automated quantitative analysis (AQUA™) and multiplexed analysis at 2 markers per slide using tumor tissue from women with stage I, stage II, or stage IIIA breast cancer treated on clinical trial SWOG-9313.

- Assess the 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 of patients who received high-dose cyclophosphamide and doxorubicin hydrochloride on clinical trial SWOG-9313.

OUTLINE: This is a multicenter study. Patients are stratified according to receptor status and menopausal status.

Tumor tissue samples are analyzed by quantitative protein expression analysis (AQUA™, a fluorescent antibody technique) for estrogen receptor, progesterone receptor, p53 and HER-2. AQUA™ is used to assess markers individually and as ratios with the use of clustering algorithms to define reproducible classifications of tissue from patients treated on SWOG-9313 as a function of molecular classification.

Results of the AQUA™ testing are compared to immunohistochemistry and fluorescent in situ hybridization (FISH) results obtained on SWOG-9313.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Yale Cancer Center
New Haven, Connecticut, United States
Status: Recruiting
Contact: Clinical Trials Office - Yale Cancer Center - 203-785-5702
Start Date
July 2006
Sponsors
Southwest Oncology Group
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page