DRKS00003947招募中2 期
Randomized, double-blinded Phase-II-trial with Docetaxel + Sorafenib (Nexavar®) versus Docetaxel + Placebo as firstline treatment for patients with HER2/neu-negative metastasized cancer of the breast. - Madonna Trial
niversitätsklinikum Heidelberg0 个研究点目标入组 288 人开始时间: 2012年12月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 288
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Female
入选标准
- •1. Histologically or cytologically confirmed stage IV adenocarcinoma of the breast or inoperable local relapse
- •2. Female patients with HER2 negative breast cancer (latest assessment)
- •3. Patients requiring first line mono-chemotherapy with taxanes
- •4. Age = 18 years.
- •5. ECOG Performance Status of = 2
- •6. Life expectancy of at least 12 weeks.
- •7. Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions must be measured by CT-scan or MRI
- •8. No prior chemotherapy for locally recurrent or metastatic disease
- •9. At least 12 months since prior adjuvant or neoadjuvant taxane therapy. Endocrine
- •treatment for early breast cancer is allowed. Patients may have failed hormonal therapy in the metastatic stage, if they are ER or PgR-positive.
- •10. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •11. Hemoglobin = 9.0 g/dl
- •12. Absolute neutrophil count (ANC) =1,500/mm3
- •13. Platelet count 100,000/µl
- •14. Total bilirubin = 1.0 times the upper limit of normal
- •15. ALT and AST = 2.5 x upper limit of normal (= 5 x upper limit of normal for patients with liver involvement of their cancer)
- •16. Alkaline phosphatase < 4 x ULN
- •17. PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
- •18. Serum creatinine = 1.5 x upper limit of normal.
- •19. Signed and dated informed consent before the start of specific protocol procedures.
排除标准
- •1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
- •2. History of HIV infection or chronic hepatitis B or C
- •3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- •4. Prior radiological or clinical evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI
- •5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •6. History of organ allograft
- •7. Patients with evidence or history of bleeding diathesis
- •8. Patients undergoing renal dialysis
- •9. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & Tl] or any cancer curatively treated > 3 years prior to study entry.
- •10. Anticancer chemotherapy or immunotherapy during the study or within 3 weeks of study entry. Hormone therapy parallel to study treatment is not allowed, but no wash-out period is necessary.
- •11. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative (radiotherapy of non-target lesions will be allowed).
- •12. Major surgery within 4 weeks of start of study
- •13. Autologous bone marrow transplant or stem cell rescue within 4 months of study
- •14. Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator; however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
- •15. Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- •16. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
- •17. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •18. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •19. Patients unable to swallow oral medications.
研究者
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