EUCTR2007-004805-80-GB进行中（未招募）不适用
Phase II trial of BIBW 2992 in patients with HER2-positive metastatic breast cancer after failure of trastuzumab therapy - Phase II in Trastuzumab Failures
未提供0 个研究点目标入组 40 人开始时间: 2007年10月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- All
入选标准
- •1. Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer (HER2 2+ and FISH positive or HER2 3+).
- •2. Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression.
- •3. Age 18 years or older.
- •4. Life expectancy of at least four (4) months.
- •5. Written informed consent that is consistent with ICH-GCP guidelines.
- •6. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2.
- •7. Patients should not have received treatment with chemotherapy or immune therapy within the last 4 weeks (2 weeks for trastuzumab). Patients should also not have received treatment with hormone therapy within the last 2 weeks.
- •8. Patients must have recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1.
- •9. Patients must have recovered from previous surgery.
- •10. Patients must have measurable disease as defined by RECIST criteria.
- •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 diarrhea.
- •3. Serious illness or concomitant non-oncological disease 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 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 cells/mm3.
- •7. Platelet count less than 100 000 cells/mm3.
- •8. Bilirubin greater than 1.5 mg/dl (>26 micromol /L, SI unit equivalent).
- •9. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal.
- •10. Serum creatinine greater than 1.5 mg/dl (>132 micromol/L, SI unit equivalent).
- •11. Women and men (and their partners) 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; chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other hormones taken for breast cancer), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. Treatment with bisphosphonates is allowed.
- •14. Prior treatment with an EGFR- or HER2 inhibiting drug (except trastuzumab).
- •15. Patients unable to comply with the protocol.
- •16. Active alcohol or drug abuse.
- •17. Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.
研究者
相似试验
已完成
2 期
Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab TherapyBreast NeoplasmsNCT00431067Boehringer Ingelheim41
进行中（未招募）
1 期
DetectIV - Treatment of patients with advanced metastatic breast cancer and circulating blood cells devoid of Her2/neu.EUCTR2013-001269-18-DEniversitätsklinikum Ulm (AöR)300
尚未招募
不适用
Efficacy analysis of anti-HER2 treatment in HER2-enriched early breast cancer identified by PAM50KCT0006154Yonsei University Health System, Gangnam Severance Hospital59
未知
2 期
Phase II clinical study of RG3502 in HER2 positive breast cancer patientsJPRN-jRCT2080221240Chugai Pharmaceutical Co., Ltd.70
招募中
不适用
A Phase II trial of preoperative HER2 targeting and endocrine therapy in postmenopausal women with HER2 and HR positive breast cancerNeoplasmsKCT0001583Yonsei University Health System, Gangnam Severance Hospital132