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

Breast Cancer Clinical Trial

Official title:

Prediction of Therapeutic Response Using AQUA™ Quantitative Protein Expression Analysis of ER, PgR, and HER2 of Breast Cancer Tissue Microarrays From SWOG Protocol 9313

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896727
• Other study ID #: CDR0000467801
• Secondary ID: SWOG-S9313-INT-0
• Status: Completed
• Start date: July 17, 2006
• Est. completion date: April 2, 2009

Study information

• Verified date: December 2019
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2100
• Est. completion date: April 2, 2009
• Est. primary completion date: January 2, 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• gene expression analysis

• protein expression analysis

Other:
• fluorescent antibody technique

• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Yale Cancer Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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