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

Breast Cancer Clinical Trial

Official title:

Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy

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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Estrogen Receptor
• Her-2
• Pgr
• Recurrence

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