跳至主要内容
临床试验/EUCTR2005-001417-18-HU
EUCTR2005-001417-18-HU进行中(未招募)不适用

A phase II Clinical Trial to Evaluate Intratumoral Injection of a Depot Formulation of Paclitaxel (DTS-301) as Neoadjuvant Therapy of Patients with Breast Cancer

DIATOS S.A.0 个研究点目标入组 10 人开始时间: 2006年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Histologically confirmed invasive primary breast cancer from core needle biopsy
  • Post-menopausal patients with hormone receptor positive tumor meaning estrogen and/or progesterone receptor positive (cut-off: 10% stained cells)
  • Single palpable tumor of 1.5 to 4 cm in diameter
  • Adequate hematological, renal and hepatic functions
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Distant metastases
  • Multicentric and bilateral breast cancer
  • Inflammatory breast disease
  • Previous radiotherapy, surgery, hormonal therapy for breast cancer
  • Previous chemotherapy for malignant disease within the past 3 years

研究者

发起方
DIATOS S.A.

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