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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00897299

First received: May 9, 2009

Last updated: May 16, 2009

Last verified: June 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

May 16, 2009

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Distant, local/regional, and ipsilateral breast relapse [ Designated as safety issue: No ]
First breast cancer recurrence [ Designated as safety issue: No ]
Relapse-free interval [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00897299 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Distant involvement at time of first recurrence [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Breast Cancer
Estrogen Receptor
Her-2
Pgr

Intervention ^ICMJE

Genetic: microarray analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Group/Cohort (s)

Not Provided

Publications *

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.
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

900

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00897299

Other Study ID Numbers ^ICMJE

CDR0000456426, ECOG-E21971CSC, NCI-7613, SANOFI-AVENTIS-ECOG-E21971CSC, GENOMIC-ECOG-E21971CSC

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:	Joseph A. Sparano, MD	Albert Einstein College of Medicine of Yeshiva University
Investigator:	Lori J. Goldstein, MD	Fox Chase Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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