EUCTR2006-002221-23-DE进行中（未招募）不适用
An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MediGene AG
- 入组人数
- 135
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. Histologically proven triple-receptor-negative metastatic or relapsed breast cancer
- •2. Minimum interval after the end of any previous taxane-containing chemotherapy regimen.
- •3. At least one tumor lesion measurable according to RECIST criteria
- •4. Gender: female
- •5. Age greater or equal to 18 years old
- •6. Negative pregnancy test (females of childbearing potential)
- •7. Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment
- •8. ECOG performance status 0, 1 or 2
- •9. Signed 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. More than 1 previous chemotherapeutic treatment for metastatic
- •or relapsed disease.
- •2. Major surgery < 4 weeks prior to enrollment
- •3. Immunotherapy <2 weeks prior to enrollment
- •4. Severe pulmonary obstructive or restrictive disease
- •5. Uncontrolled inflammatory disease (autoimmune or infectious)
- •6. Clinically significant cardiac disease (NYHA stadium > 2)
- •7. Laboratory tests (hematology, chemistry) outside specified limits:
- •WBC < or equal 3 x 10 EXP 9/L
- •ANC < or equal 1.5 x 10 EXP 9/L
- •Platelets < or equal 100 x 10 EXP 9/L
- •Hb < or equal 9.0 g/dl (< or equal 5.6 mmol/l)
- •PTT/INR > 1.5 x ULN
- •AST or ALT > 2.5 x ULN
- •Alkaline Phosphatase > 2 x ULN
- •Total Bilirubin > 1.5 x ULN
- •8. Pregnancy or nursing status
- •9. Known positive HIV testing
- •10. Known hypersensitivity to any component of the EndoTAG-1 or taxane formulations
- •11. History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
- •12. Known progressive cerebral metastasis (patients with cerebral metastases in a stable state or after successful surgical or radiological treatment are allowed to participate in the study)
- •13. History of active or significant neurological disorder and/or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
- •14. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
研究者
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