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临床试验/NCT01424865
NCT01424865Unknown不适用

Evaluation of the Co-Expression of the Cancer Stem Cell Marker ALDH1 and of HER2 as a Predictor of Adjuvant Trastuzumab Response in Breast Cancers of Women in NSABP B31

NSABP Foundation Inc0 个研究点目标入组 1,874 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,874
主要终点
ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining

研究概览

简要总结

RATIONALE: Studying samples of 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.

PURPOSE: This research trial studies biomarkers as a predictor of response to trastuzumab in samples from patients with breast cancer previously treated in the NSABP-B-31 trial.

详细描述

OBJECTIVES:

Primary

  • To determine if stem cellness identifies a poor prognostic subgroup of women with early-stage breast cancer who have been uniformly treated with either adjuvant doxorubicin hydrochloride & cyclophosphamide followed by paclitaxel (the "control arm" of B31), or the same chemotherapy plus trastuzumab.

Secondary

  • To conduct exploratory analyses to assess, to the extent possible, if co-localization of stem cellness, as determined by ALDH1 positivity, and HER2 identifies a group of patients previously considered to have HER2-negative cancers (using classical definitions) who benefit from adjuvant trastuzumab.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining

时间窗: approximately 4 years

次要结局

  • HER2 expression in cells with stem cell-like properties as a determinant of aggressiveness and response to trastuzumab in the adjuvant setting(approximately 4 years)

研究者

申办方类型
Network
责任方
Sponsor

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