CTRI/2014/01/004344尚未招募3 期
Open-label clinical study of efficacy and safety of combined therapy with Docetaxel (Biosyntez Laboratories Private Limited, India) and Doxorubicin in female patients with metastatic breast cancer
CJSC RCI Syntez Russia0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 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
入排标准
入选标准
- •1.Female patients at the age of >= 18 years old.
- •2.Patients with histologically or cytologically confirmed metastatic breast cancer.
- •3.Presence of measurable niduses as per RECIST criteria.
- •4.Absence of prior chemotherapy for metastatic breast cancer.
- •5.Presence of unresectable distant metastases.
- •6.Patients should be ambulatory and should be evaluated as per ECOG scale - 0 - 2 scores.
- •7.Adequate state of blood system and function of kidneys and liver:
- •- absolute neutrophil count (ANC) >= 1,5Ñ?109/L;
- •- platelet count >= 75Ñ?109/L;
- •- hemoglobin >= 90g/L;
- •- serum creatinine level exceeds not more than 2.5 times upper limit of normal (ULN),
- •- level of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) exceeds not more than 2.5 times ULN
- •- bilirubin level in blood serum exceeds not more than 1.5 times ULN
- •- alkaline phosphatase exceeds not more than 2.5 times ULN.
- •8.Fertile women must use a reliable method of contraception (acceptable methods of contraception in this study are: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, sustained-release injectable contraceptives, partner vasectomy and double barrier method (condom or diaphragm with spermicide) during the entire study period and for 3 months after the end of the study).
- •9.The desire and ability to sign and date the written informed consent to participate in the study prior to enrollment.
- •10.The desire and ability of the patient to comply with the protocol requirements throughout the study.
排除标准
- •1.A history of other malignancies, except for patients whose disease has not been observed for the last 5 years, patients with completely healed basal cell carcinoma or completely healed carcinoma in situ.
- •2.Presence of confirmed brain metastases.
- •3.The presence of concomitant disease or pathology, which make participation of patient in the study impossible, or any serious illness or condition that would pose a threat to patient safety in case of participation in the study - unstable angina, myocardial infarction or congestive heart failure class third or fourth, A history or present clinically significant ventricular or atrial arrhythmia more than and equal to second degree of severity.
- •4.Any organic or mental disorder, which, in the opinion of the Investigator, may interfere with the patient participation in the study or interfere with the interpretation of study results.
- •5.Presence of infections in active form.
- •6.Pregnancy and lactation.
- •7.Fertile patients who do not agree to use effective methods of contraception.
- •8.Established impossibility of drug administration in the form of intravenous infusions.
- •9.Simultaneous participation in other clinical trials.
- •10.Hypersensitivity to Docetaxel, Doxorubicin or Dexamethasone.
研究者
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