EUCTR2006-002018-36-DE进行中（未招募）不适用
An open label phase II trial to assess the efficacy and safety of a once daily oral dose of 50 mg BIBW 2992 in two cohorts of patients with HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen -
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Inclusion criteria for both cohorts of HER2-negative patients
- •1.Female Patients age 18 years or older.
- •2.Patients with histologically proven breast cancer, who failed or relapsed after no more than three lines of chemotherapy, including adjuvant.
- •3.HER2-negative patients (HER2 1+ or negative, or Her2 2+ and FISH negative if known).
- •4.Patients with at least one tumour lesion that can accurately be measured by magnetic resonance imaging (MRI), computed tomography (CT) or X-ray in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan.
- •5.Patients must have tumour samples available for EGFR-testing.
- •6.Life expectancy of at least six (6) months.
- •7.Written informed consent that is consistent with ICH-GCP guidelines and local law.
- •8.Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 or 1.
- •9. Evidence of metastatic breast cancer
- •Additional inclusion criteria for Cohort A
- •10.HR-negative patients; ER-status and PgR-status must be assessed by IHC.
- •Additional inclusion criteria for Cohort B
- •10 ER-and/or PgR-positive patients; ER-status and PgR-status must be assessed by IHC
- •11. Patients must sign informed consent form for pharmakogenetic analyses prior to analysis of EGFR/EGFR-ligand overexpression on mRNA basis
- •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.Active infectious disease.
- •2.Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea.
- •3.Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol.
- •4.Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal cerebral MRI scan at screening and be at least three months post-radiation or surgery.
- •5.Cardiac left ventricular function with resting ejection fraction < 50%.
- •6.Absolute neutrophil count (ANC) less than 1500/mm3.
- •7.Platelet count less than 100 000/mm3.
- •8.Bilirubin greater than 1.5 mg /dl (>26 µmol /L, SI unit equivalent).
- •9.Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases.
- •10.Serum creatinine greater than 1.5 mg/dl (>132 µmol/L, SI unit equivalent).
- •11.Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
- •12.Pregnancy or breast-feeding.
- •13.Treatment with other investigational drugs; other anti-cancer-therapy, e.g. chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other hormones taken for breast cancer), concomitantly with therapy on this study and/or during the past four weeks, prior to the first treatment with the trial drug. Treatment with biphosphonates is allowed.
- •14.Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors.
- •15.Patients unable to comply with the protocol.
- •16.Active alcohol or drug abuse.
- •17.Patients who have not recovered from any therapy-related toxicities of previous chemo-, hormone-, immuno-, or radiotherapies at the time of the first administration of the trial drug.
- •18. Other malignancy within the past 5 years
- •19.Patients with known pre-existing interstitial lung disease
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