Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy
Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
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無再発間隔
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Distant, local/regional, and ipsilateral breast relapse
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First breast cancer recurrence
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二次結果の測定
結果測定 |
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全生存
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無病生存
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Distant involvement at time of first recurrence
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協力者と研究者
捜査官
- Lori J. Goldstein, MD、Fox Chase Cancer Center
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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