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临床试验/ACTRN12616000786493
ACTRN12616000786493进行中(未招募)2 期

Phase II study of Paclitaxel and Epirubicin as Neoadjuvant Treatment for locally advanced Breast Cancer.

The Queen Elizabeth Hospital0 个研究点目标入组 40 人开始时间: 2016年6月16日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment

入排标准

年龄范围
18 Years 至 o limit(—)
性别
Female

入选标准

  • 1. Female aged 18 years or over with histological or cytologically confirmed locally advanced breast cancer. T3-4 Nx, Tx N2-3
  • 2. No evidence of metastatic disease.
  • 3. Normal cardiac function as determined by left ventricular injection fraction of greater that 50 % (gated heart pool scan or echocardiogram).
  • 4. ECOG performance status of 0 or 1.
  • 5. Must give written in form consent prior to commencement of any specific studies and any starting specific treatment.
  • 6. Patients must be willing and able to comply with the protocol for the duration of the study.

排除标准

  • 1. Presence of metastatic disease.
  • 2. Pregnant women or breast feeding mothers.
  • 3. Women of child bearing potential who are unable or unwilling to use contraception.
  • 4. Patients with a history of significant cardiac disease.
  • 5. Patients with a history of significant neuropathy.
  • 6. Patients with base line laboratory values with neutrophils less than 1.5 x 109/L, platelet count less than 100 x 109/L, serum creatinine greater than 1.5 x upper normal limit, serum bilirubin greater than 1.5 x upper normal limit, serum ALT or AST greater than 2.5 x upper normal limit, serum alkaline phosphatase greater than 2.5 x upper normal limit.
  • 7. No patients with any prior malignancy other than completely excised basal cell carcinoma of the skin or completely resected cervical carcinoma in-situ.
  • 8. Patients with any other uncontrolled medical condition or psychiatric condition deemed by the treating doctor to be unsuitable for treatment protocol.

研究者

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