Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy

NCT00897299 | Completed

• 5 other identifiers: CDR0000456426ECOG-E21971CSCNCI-7613SANOFI-AVENTIS-ECOG-E21971CSCGENOMIC-ECOG-E21971CSC
• Study Type: observational
• Target: 900
• 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. It may also help doctors predict whether cancer will come back after treatment. PURPOSE: This laboratory study is identifying genes that may help predict recurrence in women with breast cancer treated with chemotherapy.

Conditions

Breast Cancer; Estrogen Receptor; Her-2; Pgr

Keywords

estrogen receptor; HER-2; PgR; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (3)

• Distant, local/regional, and ipsilateral breast relapse

• First breast cancer recurrence

• Relapse-free interval

Secondary Outcomes (3)

• Distant involvement at time of first recurrence

• Disease-free survival

• Overall survival

Interventions

microarray analysis GENETIC

protein expression analysis GENETIC

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Node positive OR high-risk node negative disease * Tumor \> 1.0 cm in diameter * No locally advanced, inflammatory, or metastatic breast cancer * Previously treated with 4 courses of anthracycline-containing chemotherapy (i.e., doxorubicin and docetaxel OR doxorubicin and cyclophosphamide) * Enrolled on clinical trial ECOG-E2197 * Adequate tumor material available in ECOG Pathology Coordination Center * Previously consented to future cancer-related research * Hormone receptor status known PATIENT CHARACTERISTICS: * Female * Menopausal status 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

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Related Publications (2)

• Badve SS, Baehner FL, Gray R, et al.: ER and PR assessment in ECOG 2197: comparison of locally determined IHC with centrally determined IHC and quantitative RT-PCR. [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-87, 2007.

  RESULT

• Sparano JA, Goldstein L, Childs B, et al.: Association of individual genes with risk of relapse in operable breast cancer: analysis of E2197. [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-27, 2007.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Microarray Analysis; Immunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Microchip Analytical Procedures; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques

Study Officials

• Joseph A. Sparano, MD

  Albert Einstein College of Medicine

  STUDY CHAIR

• Lori J. Goldstein, MD

  Fox Chase Cancer Center

Study Design

• Study Type: observational
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: October 7, 2005
• Primary Completion: October 8, 2005
• Study Completion: October 8, 2005
• Last Updated: May 17, 2017

Record last verified: 2017-05