EUCTR2010-021945-29-GB进行中（未招募）1 期
X-Breast 2;An open label, phase II trial of BIBW 2992 (afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2-targeted treatment in the neoadjuvant and/or adjuvant treatment setting - LUX-Breast 2; BIBW 2992 in metastatic HER2 over-expressing breast cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 87
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
入选标准
- •1.Female patients =18 years
- •2. Proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer, Patients must have an archived tissue sample available for central re-assessment of HER2-status.
- •3.Stage IV metastatic disease.
- •4. At least one measurable lesion according to RECIST 1.1. Skin, bone and brain lesions are considered non-target lesions.
- •5. Life expectancy of at least six (6) months.
- •6. Must have failed or progressed trastuzumab or lapatanib or trastuzumab and
- •lapatanib treatment in the neoadjuvant and/or adjuvant setting and on BIBW
- •2992 (afatinib) monotherapy in the 1st line metastatic setting (for patients in the second part of the trial).
- •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 53
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •1. Requirement for treatment with any of the prohibited concomitant medications
- •2. Quickly progressing visceral disease
- •3. Known pre-existing interstitial lung disease
- •4. Prior first line therapy for metastatic breast cancer
- •5. Radiotherapy, chemotherapy, immunotherapy, trastuzumab or lapatinib treatment or surgery (other than biopsy) within 4 weeks prior to trial treatment. Treatment with palliative radiotherapy (short course to non-target lesions) is allowed.
- •6. Hormone therapy for breast cancer within 2 weeks prior to trial treatment
- •7. Active brain metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring changes of treatment with anticonvulsants or steroids and/or leptomeningeal disease).
- •8. Any other current malignancy or malignancy diagnosed within the past five (5) years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomatous skin cancer and in situ cervical cancer).
- •9. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn's disease, malabsorption or CTC grade =2 diarrhoea of any aetiology.
- •10. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia
- •11. Myocardial infarction within 6 months prior to trial treatment.
- •12. Cardiac left ventricular function with resting ejection fraction of less than 50%
- •13. Absolute neutrophil count (ANC) < 1.5 x 109/L
- •14. Calculated Creatinine clearance < 60 ml / min (Cockcroft formula – Appendix 1) or serum creatinine > 1.5 times upper limit of normal
- •15. Bilirubin > 1.5 times upper limit of normal.
- •16. Aspartate amino transferase (AST) or alanine amino transferase (ALT) > three times the upper limit of normal (ULN) (if related to liver metastases > five times ULN).
- •17. Prior treatment with paclitaxel in the past 12 months.
- •18. Platelet count < 100 x 109/L
研究者
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