EUCTR2011-001765-41-DE进行中（未招募）1 期
Single-arm, open-label, multicentre phase II study evaluating the efficacy and safety of BIBW 2992 (Afatinib) in combination with vinorelbine for the treatment of patients with metastatic breast cancer with intermediate HER2 expression (HER2 2+ by immunohistochemistry, fluorescence in-situ hybridisation (FISH) negative) after failure of first-line therapy in the metastatic setting and having been pre-treated with anthracyclines - BIBW 2992 (Afatinib) and vinorelbine
Medizinische Fakultät der Otto-von-Guericke Universität Magdeburg Universitätsklinikum Magdeburg A.ö.R.0 个研究点目标入组 0 人开始时间: 2011年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Female patients = 18 years
- •2. Histologically confirmed diagnosis of intermediate HER2-overexpressing breast cancer
- •3. Stage IV metastatic disease
- •4. Must have received anthracycline-based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
- •5. Must have received one first-line chemotherapy for metastatic breast cancer
- •6. Must have (archived) tumour tissue sample available for central re-assessment of HER2 status and prove to be intermediate HER2-positive. HER2 intermediate status is defined as IHC 2+ and FISH-negativity.
- •7. Must have at least one measurable lesion according to RECIST 1.1 (R09-0262). Patient with only skin lesions will not be eligible.
- •8. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (R01-0787).
- •9. Life expectancy of at least six (6) months.
- •10. Written informed consent that is consistent with ICH-GCP guidelines.
- •11. Must be eligible for treatment with BIBW 2992 and vinorelbine.
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Prior treatment with EGFR/HER2-targeted tyrosine kinase inhibitors, i.e. lapatinib
- •2. Prior treatment with vinorelbine
- •3. Known pre-existing interstitial lung disease
- •4. Radiotherapy, chemotherapy, hormone therapy, immunotherapy or surgery (other than biopsy) within 4 weeks (2 weeks for hormone therapy) prior to start of treatment with BIBW 2992 and vinorelbine.
- •5. Active brain metastases (defined as stable for < 4 weeks and/or symptomatic and/or requiring changes of treatment with anticonvulsants or steroids within the past 4 weeks and/or leptomeningeal disease). Patients with known history of brain metastases should undergo a baseline brain imaging by e.g. CT scan or MRI to ensure that the disease is stable.
- •6. 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.
- •7. 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. Myocardial infarction within 6 months prior to start of study treatment.
- •8. Cardiac left ventricular function with resting ejection fraction of less than 50 %.
- •9. Women of childbearing potential, unwilling to use a medically acceptable method of contraception during the trial, see Section 5.2.2.4.
- •10. Pregnancy or breast-feeding.
- •11. Known hepatitis B infection, known hepatitis C infection or known HIV carrier.
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