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临床试验/CTRI/2023/03/051117
CTRI/2023/03/051117招募中2 期

To compare the efficacy and safety of Paclitaxel vs Paclitaxel and Carboplatin combination regimens in patients with HER2/neu negative metastatic breast carcinoma

ALL INDIA INSTITUTE OF MEDICAL SCIENCES Jodhpur0 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
招募中
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. Written informed consent.
  • 2. Treatment naive metastatic HER2/neu negative breast cancer patients requiring chemotherapy.
  • 3. Age group 18 to 75 years.
  • 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

排除标准

  • 1. Known case of cardiac diseases (congestive heart failure, Myocardial infarction in past 1 year).
  • 2. Pregnancy and lactating women.
  • 3. Patients with CNS metastasis
  • 4. Known cases of psychiatric illness
  • 5. Patients with Sepsis
  • 6. Clinically relevant peripheral neuropathy
  • 7.Pancytopenia (neutropenia (Absolute neutrophil count < 1.5x109/l), thrombocytopenia (Platelet count <100x109 /l), anemia).
  • 8.Serum creatinine > 2.7 mg/dL & Creatine clearance <30ml
  • 9. Serum total bilirubin > 1.5 times the upper limit of normal
  • 10.ASAT (SGOT) and ALAT (SGPT) > 3x UNL

研究者

发起方
ALL INDIA INSTITUTE OF MEDICAL SCIENCES Jodhpur

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