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临床试验/ISRCTN12618919
ISRCTN12618919已完成不适用

A Multicentre, Phase II, Neoadjuvant Chemotherapy in Palpable Breast Cancer: Evaluation of Physiologic, Radiologic, and Molecular Markers in Predicting Response

ational Cancer Institute (NCI) (USA)0 个研究点目标入组 100 人开始时间: 2010年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
Female

入选标准

  • 1. Women, aged = 18
  • 2. Diagnosis of invasive breast cancer
  • 3. Tumor more than 3 cm and palpable
  • 4. Multiple masses are allowed provided at least 1 mass is more than 3 cm
  • 5. Clinically positive axillary or supraclavicular lymph nodes allowed
  • 6. Fine needle aspiration or core needle biopsy positive for invasive breast cancer AND/OR fine needle aspiration of lymph nodes positive
  • 7. Estrogen receptor (ER)-positive OR ER-negative
  • 8. ER2/neu-positive OR negative
  • 9. Premenopausal or postmenopausal
  • 10. Performance status: Karnofsky 60-100%
  • 11. Granulocyte count more than 1,000/mm^3
  • 12. Platelet count more than 100,000/cmm
  • 13. Bilirubin more than 2 times upper limit of normal (ULN)
  • 14. Serum glutamic oxaloacetic transaminase (SGOT) more than 2 times ULN
  • 15. Left Ventricular Ejection Fraction (LVEF) not less than 50%

排除标准

  • 1. Inflammatory breast cancer
  • 2. Distant metastases
  • 3. Congestive heart failure or other significant cardiovascular disease
  • 4. Pregnancy or nursing
  • 5. Severe medical or psychiatric condition that would preclude study compliance
  • 6. HIV positivity
  • 7. Patients with other prior or concurrent malignancies if they have received prior chemotherapy or are not cured from the prior malignancy

研究者

发起方
ational Cancer Institute (NCI) (USA)

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eoadjuvant Chemotherapy in Palpable Breast Cancer:... | 临床试验