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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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무재발 간격
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Distant, local/regional, and ipsilateral breast relapse
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First breast cancer recurrence
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2차 결과 측정
결과 측정 |
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전반적인 생존
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무질병 생존
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Distant involvement at time of first recurrence
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공동 작업자 및 조사자
수사관
- Lori J. Goldstein, MD, Fox Chase Cancer Center
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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