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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-17

Study Completion Date

2009-04-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

gene expression analysis

Intervention Type GENETIC

protein expression analysis

Intervention Type GENETIC

fluorescent antibody technique

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Rimm, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SWOG-S9313-INT-0137-ICSC

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-00806