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临床试验/ISRCTN81164554
ISRCTN81164554已完成不适用

Adjuvant cyclophosphamide, methotrexate and 5-Fluorouracil (CMF) versus 5-Fluorouracil, epirubicin and cyclosphosphamide (FEC) in node negative poor-risk primary breast cancer

Pharmacia Ltd & Upjohn (UK)0 个研究点目标入组 0 人开始时间: 2002年8月19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

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. Aged less than 65 years
  • 2. Histologically proven invasive adenocarcinoma axillary nodes must be histologically negative
  • 3. Tumour is T1c to T3
  • 4. Tumour shows one of the following features of poor prognosis:
  • 4.1. Oestrogen receptor less than or equal to 10 fmol/mg cytosol protein
  • 4.2. Grade III
  • 4.3. Vessel invasive
  • 4.4. High labelling index of S phase
  • 4.5. Aneuploidy
  • 4.6. Tumour size at least 2 cm
  • 5. Adequate renal, hepatic and haematological function
  • 6. No evidence of metastatic disease
  • 7. No evidence of inflammatory carcinoma
  • 8. Patients with bilateral malignancy or with a mass in the opposite breast, unless there is biopsy proof that it is not a malignancy, are excluded
  • 9. Patients with findings that relate them to a category of more advanced disease are not eligible
  • 10. Patients with clinically positive nodes in the axilla opposite the affected breast, or with palpable supraclavicular or infraclavicular nodes are considered ineligible unless there is a biopsy evidence that these are not involved with the tumour
  • 11. No previous or concomitant malignancy, except squamous or basal cell carcinoma which has been effectively treated and carcinoma in situ of the cervix which has been treated operatively
  • 12. No prior therapy for the present breast cancer including radiotherapy, chemotherapy, immunotherapy and/or hormonal therapy
  • 13. No non-malignant systemic disease which would preclude their being subjected to any of the treatment options or prevent prolonged follow up
  • 14. No active or previous cardiac disease that would preclude the use of 4-epidoxorubicin
  • 12. No psychiatric or addictive disorders which should preclude obtaining informed consent

排除标准

  • Not provided at time of registration

研究者

发起方
Pharmacia Ltd & Upjohn (UK)

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