EUCTR2006-005912-28-SE进行中（未招募）不适用
Study EGF107671 – a Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy.
适应症
相关药物
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
- All
入选标准
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •1. Signed written informed consent;
- •2. Females or males age = 18 years old;
- •3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
- •4. Life expectancy of at least 12 weeks;
- •5. Subjects must have histologically or cytologically confirmed invasive breast cancer,
- •with Stage IV disease;
- •6. ErbB2 overexpressing breast cancer, defined as 3+ staining by
- •immunohistochemistry (IHC), or 2+ staining by IHC in conjunction with ErbB2 gene
- •amplification by FISH, or ErbB2 gene amplification by FISH alone.
- •7. At least one measurable lesion in the brain, defined as any lesion =10 mm in longest dimension. Measurable brain lesions should not have been treated with prior stereotactic radiosurgery (SRS); an exception being a brain lesion whose longest linear dimension increased = 50% following SRS and whose absolute longest dimension now measures = 15mm;
- •8. Prior treatment of brain metastases with WBRT and/or SRS;
- •9. Unequivocal evidence of new and / or progressive lesions in the brain on an imaging study; (view protocol).
- •10. Prior treatment with trastuzumab, either alone or in combination with chemotherapy is required. Trastuzumab will be discontinued at least 2 weeks prior to enrollment on study;
- •11. Cardiac ejection fraction within institutional range of normal as measured by
- •echocardiogram. Subjects who require cardiac medications (e.g. positive inotropic
- •agents or afterload reducers) for normal ejection fraction are ineligible. MUGA
- •scans will be accepted in cases where an echocardiogram cannot be performed or is
- •inconclusive;
- •12. At least 2 weeks since prior radiotherapy, last chemotherapy, immunotherapy,
- •biologic therapy, or hormonal therapy for cancer, and sufficiently recovered or
- •stabilized from side effects associated with prior therapy. Concurrent treatment with
- •bisphosphonates is permitted;
- •13. At least 3 weeks since major surgical procedures;
- •14. Able to swallow and retain oral medications;
- •15. Women of childbearing potential must have a negative serum pregnancy test at
- •screening and must use an approved contraceptive method, if appropriate (for
- •example, intrauterine device [IUD], birth control pills, or barrier device) beginning 2
- •weeks before the first dose of investigational product and for 28 days after the final
- •dose of investigational product. Males able to father a child must practice adequate
- •methods of birth control or practice complete abstinence from intercourse from the
- •first dose of investigational treatment until one week after the final dose of
- •investigational treatment.
- •16. Subjects must complete all screening assessments as outlined in the protocol;
- •17. Subjects must have normal organ and marrow function as defined (please view protocol).
- •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
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. Subjects who have had chemotherapy or radiotherapy within 2 weeks prior to
- •entering the study or who have unresolved or unstable, serious toxicity from prior
- •administration of another investigational drug and/or of prior cancer treatment;
- •2. Concurrent treatment with an investigational agent or participation in another
- •treatment clinical trial;
- •3. Prior therapy with a topoisomerase 1 inhibitor;
- •4. Prior lapatinib therapy;
- •5. Prior therapy with capecitabine;
- •6. Known dihydropyrimidine dehydrogenase (DPD) deficiency;
- •7. ECOG Performance Status 2 or greater;
- •8. Subjects receiving concurrent chemotherapy, radiation therapy, immunotherapy,
- •biologic therapy (including an ErbB1 and/or ErbB2 inhibitor), or hormonal therapy
- •for treatment of their cancer. Hormone therapy for ovarian suppression which has
- •been used for > 6 months, during which time there has been disease progression in the brain, is allowed. Concurrent treatment with bisphosphonates is allowed;
- •9. Subjects with evidence of leptomeningeal carcinomatosis at screening;
- •10. History of allergic reactions attributed to compounds of similar chemical
- •composition (quinazolines) to lapatinib;
- •11. History of allergic reactions attributed to compounds chemically related to
- •capecitabine, fluorouracil or any excipients;
- •12. Concurrent treatment with medications listed in Section 7.2 and Section 13.6,
- •Prohibited Medications;
- •13. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled
- •ulcerative colitis are also excluded;
- •14. History of immediate or delayed hypersensitivity reaction to gadolinium contrast
- •agents, or other contraindication to gadolinium contrast;
- •15. Other known contraindication to MRI, such as a cardiac pacemaker, implanted
- •cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or
- •16. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety;
- •17. Anticoagulant therapy at study entry (other than coumadin or aspirin as catheter
- •prophylaxis, or a low dose heparin [i.e. 50 unit unfractionated] flush of a central
- •venous device);
- •18. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent, unless a legally acceptable
- •representative could provide informed consent (if in accord with the policies of the
- •local Ethics Committee);
- •19. Pre-existing severe cerebral vascular disease, such as stroke involving a major
- •vessel, CNS vasculitis, or malignant hypertension;
- •20. Active cardiac disease, defined as one or more of the following:
- •History of uncontrolled or symptomatic angina
- •History of arrhythmias requiring medications, or clinically significant
- •Myocardial infarction < 6 months from study entry
- •Uncontrolled or symptomatic congestive heart failure
- •Ejection fraction below the institutional normal limit
- •Any other cardiac condition, which in the opinion of the treating physician,
- •would make this protocol unreasonably hazardous for the patient;
- •21. Uncontrolled infection;
- •22. Pregnant or lactating females;
- •23. History of other malignancy, except for curatively treated basal cell carcinoma or
- •squamous cell carcinoma of the skin, or carcinoma in situ o
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