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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00897299
Other study ID # CDR0000456426
Secondary ID ECOG-E21971CSCNC
Status Completed
Phase N/A
First received May 9, 2009
Last updated May 16, 2017
Start date October 7, 2005
Est. completion date October 8, 2005

Study information

Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 900
Est. completion date October 8, 2005
Est. primary completion date October 8, 2005
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Intervention

Genetic:
microarray analysis

protein expression analysis

Other:
immunohistochemistry staining method

laboratory biomarker analysis


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

References & 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 Septemb

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,

Outcome

Type Measure Description Time frame Safety issue
Primary Distant, local/regional, and ipsilateral breast relapse
Primary First breast cancer recurrence
Primary Relapse-free interval
Secondary Distant involvement at time of first recurrence
Secondary Disease-free survival
Secondary Overall survival
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