PER-056-09已完成未知
Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients
Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI),0 个研究点目标入组 0 人开始时间: 2009年10月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
- 性别
- Female
入选标准
- •Female patients 18 years of age or older.
- •Histologically proven breast cancer patients who have not received any previous therapy.
- •Locally advanced Stage IIIA disease without evidence of distant metastatic disease in addition to the lymph nodes of the anatomical site.
- •HER2-positive patients (IHC HER2 3+, or HER2 2+ and FISH positive).
- •Patients with at least one lumoral lesion> 5 cm in diameter that can be accurately measured by clinical measurement and ultrasound in at least one dimension (the longest recorded diameter).
- •Patients must give their consent to undergo biopsies of fresh tumor tissue (fresh and paraffin-preserved material) taken to perform HER2 and biomarker analyzes for incorporation into the study, after 3 weeks of treatment and in the EOT.
- •Life expectancy of at least 6 months.
- •Informed written consent that is consistent with ICH-BPC guidelines and local legislation.
- •Eastem Cooperative Oncology Group (ECOG, ROl-0787) score of 0 or 1.
排除标准
- •Absolute neutrophil count (ANO) less than 1,500 / mm3.
- •Platelet count less than 100,000 / mm3.
- •Hemoglobin level less than 9.0 g / dl.
- •Bilirubin greater than 1.5 mg / dl (> 26 pmol / L, equivalent unit of SI).
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than double the upper limit of the standard
- •Serum creatinine greater than 1.5 times the normal upper limit or calculated / measured creatinine clearance <45 ml / min.).
- •Significant or recent acute gastrointestinal disorders with diarrhea as the main symptom, eg Crohn´s disease, malabsorption, or CTCAE diarrhea Grade> 2 of any etiology in the initial evaluation.
- •Serious illness, concomitant non-cancer disease or mental problems that the researcher considers incompatible with the protocol.
- •Sexually active patients who are not willing to use a medically acceptable contraceptive method.
- •Pregnancy or breastfeeding.
- •Patients who cannot comply with the protocol.
- •Active alcohol or drug abuse.
- •Patients who have any other life-threatening organic disease or dysfunction that, in the opinion of the researcher, would compromise the patient´s safety or interfere with the safety assessment of the study drug.
- •Previous treatment for previous locally advanced breast cancer including treatment with other investigational drugs; other cancer therapies, e.g. chemotherapy, immunotherapy, radiotherapy or hormonal therapy (including LHRH agonists, or other endocrine / hormonal therapies for breast cancer), concomitantly with the treatment of this trial and / or during the last 4 weeks prior to the first treatment with the trial drug. Simultaneous treatment with bisphosphonates is allowed.
- •Previous treatment with Trastuzumab or EGFR or EGFR / HER2 inhibitors.
- •Other malignant tumors diagnosed in the last five (5) years (other than non-melanomato skin cancer and cervical cancer in situ).
- •Patients with any active infection would be 4 ^ s_ say, which requires an IV antibiotic, antifungals, or antiviral agents).
- •Patients with known HIV, active hepatitis B or active hepatitis C.
- •History of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, acute myocardial infarction, arrhythmias, including functional classification of 3 according to the New York Heart Association (NYHA).
- •Cardiac function of the left ventricle with a resting ejection action of less than 50% measured according to the nuclear ventriculography of the heart (MUGA scan) or echocardiogram.
研究者
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