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临床试验/CTRI/2017/10/010272
CTRI/2017/10/010272尚未招募2 期

Docetaxel and Carboplatin (DC) versus 5-Flurouracil, Epirubicin, Cyclophosphamide (FEC) and Docetaxel (D)as neoadjuvant chemotherapy in triple negative, non-metastatic breast cancer: a randomized trial.

Jawaharlal Institute of Post Graduate Medical Education and research0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
尚未招募
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

入选标准

  • 1.Newly diagnosed, Histologically confirmed Triple negative Breast cancer ER <1%, PR <1% (IHC), HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH negative].
  • 2. Stages 2 and 3 according to AJCC edition7,( see appendix 1. )
  • 3. Has provided written Informed Consent for participation in this trial
  • 4. Adequate Haematological, renal, hepatic and pulmonary functions as defined by, examples
  • ï?? Absolute neutrophil count (ANC, segs + bands), 1.5 x 109/L
  • ï?? Platelet count, 100 x 109/L
  • ï?? Total bilirubin, 1.5 x upper normal
  • ï?? Alanine aminotransferase (ALT), 2.5 x upper normal limit
  • ï?? Calculated creatinine clearance > 60ml/min (Cockcroft-Gault formula )
  • 5. An ECOG performance status score of [0,1]
  • 6. Participants capable of childbearing are using adequate contraception
  • 7. Available for follow up

排除标准

  • 1. Male Breast cancer
  • 2. Her2 neu 2+ but not confirmed with FISH
  • 3. Women who are pregnant or lactating.
  • 4. Past or current history of another malignancy
  • 5. Previous radiotherapy

研究者

发起方
Jawaharlal Institute of Post Graduate Medical Education and research

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