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

NCT ID: NCT00897299

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-07
• Study Completion Date: 2005-10-08

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.

Detailed Description

OBJECTIVES:

• Assess the prognostic utility of the Oncotype DX™ 21 gene profile for risk of relapse in women with node positive or high-risk node negative breast cancer.
• Identify individual genes whose RNA expression is associated with an increased risk of relapse in these patients.
• Perform an exploratory analysis of individual genes whose RNA expression is associated with an increased risk of relapse differentially in patients previously treated with docetaxel.

OUTLINE: This is a multicenter study.

Tissue samples are examined for association of RNA expression and clinical factors (e.g., tumor size, nodal status, hormone receptor status, age, menopause status), as well as estrogen receptor, progesterone receptor, and HER-2/neu expression by immunohistochemistry and other studies.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.

Conditions

Breast Cancer; Estrogen Receptor; Her-2; Pgr

Interventions

microarray analysis

Intervention Type: GENETIC

protein expression analysis

Intervention Type: GENETIC

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Joseph A. Sparano, MD

Role: STUDY_CHAIR

Albert Einstein College of Medicine

Lori J. Goldstein, MD

Role:

Fox Chase Cancer Center

References

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.

Reference Type: 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.

Reference Type: RESULT

Other Identifiers

ECOG-E21971CSC

Identifier Type: -

Identifier Source: secondary_id

NCI-7613

Identifier Type: -

Identifier Source: secondary_id

SANOFI-AVENTIS-ECOG-E21971CSC

Identifier Type: -

Identifier Source: secondary_id

GENOMIC-ECOG-E21971CSC

Identifier Type: -

Identifier Source: secondary_id

CDR0000456426

Identifier Type: -

Identifier Source: org_study_id