CTRI/2013/12/004208尚未招募未知
Open-label, comparative clinical study of the efficacy and safety of combined therapy with Paclitaxel (Biosyntez Laboratories Private Limited, India) and Doxorubicin in comparison to Taxol® (Bristol-Myers Squibb S.r.L., Italy) and Doxorubicin in female patients with metastatic breast cancer after failure of standard combination therapy.
CJSC RCI Syntez Russia0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
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
- •Female patients at the age of >= 18 years old.
- •Patients with histologically or cytologically confirmed metastatic breast cancer.
- •Presence of measurable niduses as per RECIST criteria and presence of disease progression signs after previous therapy.
- •History of operative therapy and/or radiation treatment regimen.
- •Presence of unresectable distant metastases.
- •There should be, at least, 4 weeks after radiation therapy and, at least, 6 weeks after previous chemotherapy.
- •Previous therapy toxicity manifestation should be completely resolved.
- •Patients should be ambulatory and should be evaluated as per ECOG scale - 0 - 2 scores.
- •Adequate state of blood system and function of kidneys and liver:
- •- absolute neutrophil count (ANC) >= 1.5Ñ?109/L;
- •- platelet count >= 100Ñ?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
- •- negative serum HCG;
- •Fertile women must use a reliable method of contraception during the entire study period and for 3 months after the end of the study.
- •The desire and ability to sign and date the written informed consent to participate in the study prior to enrollment.
- •The desire and ability of the patient to comply with the protocol requirements throughout the study.
排除标准
- •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.
- •Presence of confirmed brain metastases.
- •More than two courses of previous chemotherapy for breast cancer, including adjuvant and neoadjuvant therapy.
- •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.
- •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.
- •Gastric and duodenal ulcer disease
- •Presence of infections in active form.
- •Pregnancy and lactation
- •Fertile patients who do not agree to use effective methods of contraception.
- •Established impossibility of drug administration in the form of intravenous infusions.
- •Simultaneous participation in other clinical trials.
- •Hypersensitivity to Paclitaxel, Doxorubicin or Dexamethasone and other drug excipients.
- •Severe organic renal lesion, diabetes mellitus, chronic arterial insufficiency, thyroid diseases
- •Diseases of the central and peripheral nervous system, psychiatric disorders, including depressive disorders, seizures
- •Major surgery within two weeks prior to the study
- •Peripheral neuropathy more than second degree of severity
- •Active systemic infection requiring treatment
研究者
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