EUCTR2005-005581-36-FI进行中（未招募）不适用
Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (25 mg vs. 100 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Patients must meet all of the following inclusion criteria:
- •1. Postmenopausal women defined as:
- •- aged >/= 50 years with amenorrhea for at least 12 months or
- •- aged stimulating
- •- hormone (FSH) level within postmenopausal range (> 40 mIU/ml) or
- •- having undergone bilateral oophorectomy
- •2. Histologically or cytologically confirmed breast cancer
- •3. Metastatic breast cancer (Stage IV according to UICC – Union internationale
- •Contre Cancer - criteria)
- •4. Progesterone receptor (PR)-positive tumors
- •5. Patients must be considered candidates for endocrine therapy (no other
- •therapies for breast cancer are required)
- •6. Disease progression after first-line endocrine therapy for advanced breast cancer
- •(i.e. with tumor remission or stabilization lasting at least 3 months under
- •endocrine therapy)
- •7. At least one measurable or non measurable tumor lesion (according to RECIST
- •8. WHO Performance status 2 or lower
- •9. Adequate function of major organs and systems
- •Hematopoietic:
- •- Hemoglobin: >= 10 g/dL
- •- Absolute neutrophil count: >= 1,500/mm3
- •- Platelet count: >= 100,000/mm3
- •- Total bilirubin: <=1.5 times the upper limit of normal
- •- AST/ALT: <=2.5 times the upper limit of normal
- •- Creatinine: <=1.5 times the upper limit of normal
- •Gynecological:
- •- Endometrial thickness (in non-hysterctomised women)
- •= 5mm double layer
- •No other uncontrolled concurrent illness
- •10. Adequate recovery from previous surgery, radiation and chemotherapy
- •11. Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who meet any of the following criteria will be excluded:
- •1. Presence of any of the following conditions:
- •- life-threatening metastatic visceral disease (extensive hepatic involvement)
- •- any metastases to the central nervous system (CNS)
- •- pulmonary lymphangitic metastases involving more than 50% of the lung
- •2. More than one prior endocrine treatment for advanced breast cancer
- •New 3. Previous chemotherapy or endocrine combination treatment for metastatic breast cancer are not permitted in this trial
- •New 4. Patients with breast cancer HER-2 positive or unknown HER-2 status are not eligible
- •New 5. (former 3.) Malignancies or history of prior malignancy other than carcinoma in situ of the cervix or uterus, or basal and squamous cell carcinoma of the skin
- •New 6. (fomer 4.) Intake of CYP3A4 inhibitors less than 2 weeks before start of study treatment
- •New 7. (former 5.) A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms))
- •New 8. (former 6.) A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- •New 9. (former 7.) The use of concomitant medications that prolong the QT/QTc interval (
- •New 10. (former 8.) Other investigational drug therapies less than 4 weeks before start of study treatment
- •New 11. (former 9.) Expectation that the patient will not be able to complete at least 3 months of therapy
- •New 12 (former 10.) Unwillingness or inability to comply with the protocol
研究者
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