EUCTR2005-005581-36-AT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）
- 发起方
- Schering AG
- 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
- •1. 1.Postmenopausal women defined as:
- •- aged >/= 50 years with amenorrhea for at least 12 months or
- •- aged - 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 criteria)
- •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:
- •- Normal endometrial thickness (in non-hysterectomized women)
- •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
- •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
- •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
- •4. Intake of CYP3A4 inhibitors less than 2 weeks before start of study treatment
- •5. Other investigational drug therapies less than 4 weeks before start of study treatment
- •6. Expectation that the patient will not be able to complete at least 3 months of therapy
- •7. Unwillingness or inability to comply with the protocol
研究者
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