ISRCTN58771616终止2 期
A randomised phase II screening trial with functional imaging and patient reported toxicity sub-studies comparing Lapatinib plus capecitabine versus continued Trastuzumab plus capecitabine after local therapy in patients with ErbB2-positive metastatic breast cancer developing brain metastasis/es
eeds Teaching Hospitals NHS Trust (UK)0 个研究点目标入组 30 人开始时间: 2011年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32600919/ results (added 22/07/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female aged greater than or equal to 18 years
- •2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •3. Given written informed consent prior to any trial specific procedures
- •4. Expected survival greater than or equal to 12 weeks
- •5. Histologically or cytologically confirmed invasive breast cancer, with stage IV disease including newly diagnosed central nervous system (CNS) metastasis/es
- •6. ErbB2 overexpression in the invasive component of the primary or metastatic lesion as locally defined by:
- •7.1. 3+ staining by immunohistochemistry (IHC)
- •7.2. 2+ staining by IHC in conjunction with ErbB2 gene amplification by FISH
- •7.3. ErbB2 gene amplification by FISH
- •8. Participants with a negative or equivocal overall result are not eligible for inclusion in the trial
- •9. Evidence of metastatic brain disease. To be considered evaluable for the primary endpoint and the CNS response rates endpoints, participants must have at least one measurable brain lesion that can be accurately measured in at least one dimension (shortest dimension to be recorded) as greater than 20 mm with conventional techniques or as greater than 10 mm with spiral computed tomography (CT) scan. Participants with leptomeningeal disease are not eligible for participation in the trial due to the lack of measurable disease.
- •10. Treated previously with taxanes or anthracyclines in the adjuvant or metastatic setting. All treatment related adverse events must be less than or equal to grade 1 at the time of randomisation.
- •11. Prior treatment with trastuzumab is required and all treatment related adverse events must be less than or equal to Grade 1 at the time of randomisation
- •12. Completed local cranial therapy (stereotactic radio surgery or whole brain radiotherapy)
- •13. Able to swallow and retain oral medication
- •14. Normal organ and bone marrow function as defined below:
- •15.1. Leukocytes greater than 3,000/µL
- •15.2. Absolute neutrophil count greater than 1,500/µL
- •15.3. Platelets greater than 100,000/µL
- •15.4. Total bilirubin within normal institutional limits
- •15.5. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) less than or equal to 2.5 x institutional upper limits of normal
- •15.6. Creatinine within normal institutional limits or creatinine clearance greater than or equal to 60 ml/min/1.73 m^2 for participants with creatinine levels above institutional normal
- •16. Cardiac ejection fraction greater than or equal to 50% or within the institutional limit as measured by echocardiogram scan. Note that the baseline and on treatment scan should be performed using the same modality and preferably the same institution.
排除标准
- •1. Prior therapy with lapatinib or an ErbB2 inhibitor other than trastuzumab
- •2. Prior treatment with capecitabine
- •3. Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including an ErbB1 and/or ErbB2 inhibitor), or hormonal therapy for treatment of cancer
- •4. Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •5. Current active hepatic or biliary disease (with exception of participants with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •6. Pregnant or lactating females. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to trial entry and for the duration of the trial participation.
- •7. History of significant non-breast malignancy (aside from non-melanomatous skin cancer, carcinoma in situ of the uterine cervix, superficial bladder cancer treated with curative intent)
- •8. History of allergic reactions attributed to compounds of a similar chemical or biological composition as to lapatinib
- •9. Uncontrolled inter-current illness including, but not limited to:
- •9.1. Ongoing or active infection
- •9.2. Symptomatic congestive heart failure
- •9.3. Unstable angina pectoris
- •9.4. Cardiac arrhythmia
- •9.5. Psychiatric illness/social situations that would limit compliance with trial requirements
- •10. Gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
- •11. Renal function as measured by creatinine clearance less than 30 ml/min (ratio to norm less than 0.1)
- •12. Not recovered from adverse events due to agents administered more than 4 weeks earlier with the exception of adverse events less than or equal to grade 1 after previous chemotherapy
- •13. Prior treatment with epidermal growth factor receptor (EGFR) targeting therapies
- •14. Active cardiac disease, defined as:
- •14.1. History of uncontrolled angina
- •14.2. History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
- •14.3. Myocardial infarction less than 6 months from trial entry
- •14.4. Uncontrolled or symptomatic congestive heart failure
- •14.5. Ejection fraction below 50% or the institutional lower normal limit
- •14.6. Any other cardiac condition, which in the opinion of the treating investigator, would make this protocol unreasonably hazardous for the participant
- •15. Any concomitant medications or substances forming part of the part of normal ongoing care locally known to affect, or have the potential to affect, the activity or pharmacokinetics of lapatinib
研究者
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