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临床试验/NCT00870168
NCT00870168已完成不适用

Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.

Centre Jean Perrin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Changes in hormone receptor expression

研究概览

简要总结

RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.

详细描述

OBJECTIVES:

Primary

  • Evaluate the effect of first-line chemotherapy on expression of hormone receptors and biomarkers in women with metastatic breast cancer.

Secondary

  • Assess changes in HER1 and HER2 expression during treatment.

研究设计

研究类型
Interventional
主要目的
Treatment

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

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed adenocarcinoma of the breast
  • Metastatic disease
  • No inflammatory breast cancer
  • Measurable disease according to RECIST criteria
  • Hormone receptor status:
  • Estrogen receptor- and/or progesterone receptor-negative by IHC
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • WHO performance status 0-2
  • Life expectancy > 3 months
  • ANC > 1.5 x 10^9/L
  • Platelet count > 100 x 10^9/L
  • Liver transaminases ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ 2 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No allergy to xylocaine
  • No heart failure, or kidney, bone marrow, respiratory, or liver insufficiency
  • PRIOR CONCURRENT THERAPY:
  • No prior first-line treatment for metastatic disease

排除标准

  • 未提供

结局指标

主要结局

Changes in hormone receptor expression

次要结局

未报告次要终点

研究者

发起方
Centre Jean Perrin
申办方类型
Other

研究点 (2)

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