Clinical trial NCT00897299: Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy
Official title: Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Estrogen Receptor
Her-2
Pgr
Keywords: estrogen receptor
HER-2
PgR
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility 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

Primary outcomes:
measure: Distant, local/regional, and ipsilateral breast relapse
measure: First breast cancer recurrence
measure: Relapse-free interval
Secondary outcomes:
measure: Distant involvement at time of first recurrence
measure: Disease-free survival
measure: Overall survival
Other outcomes:
Locations:
Study officials:
affiliation: Albert Einstein College of Medicine
name: Joseph A. Sparano, MD
role: STUDY_CHAIR
affiliation: Fox Chase Cancer Center
name: Lori J. Goldstein, MD
References:
citation: 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.
citation: 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.