Text Size

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
  Purpose

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.


Condition Intervention
Breast Cancer
Estrogen Receptor
Her-2
Pgr
 Genetic: microarray analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 900
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897299

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Joseph A. Sparano, MD Albert Einstein College of Medicine of Yeshiva University
Investigator: Lori J. Goldstein, MD Fox Chase Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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.

ClinicalTrials.gov Identifier: NCT00897299     History of Changes
Other Study ID Numbers: CDR0000456426, ECOG-E21971CSC, NCI-7613, SANOFI-AVENTIS-ECOG-E21971CSC, GENOMIC-ECOG-E21971CSC
Study First Received: May 9, 2009
Last Updated: May 16, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
estrogen receptor
HER-2
PgR
 stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013