EUCTR2006-001907-13-IT进行中（未招募）不适用
ETROZOLE versus LETROZOLE PLUS LAPATINIB GW572016 IN HORMONE-SENSITIVE, HER-2 NEGATIVE OPERABLE BREAST CANCER. A DOUBLE BLIND RANDOMIZED PHASE II STUDY WITH BIOMARKER EVALUATION - LAP107692 - LETLOB
GLAXO SMITH KLINE RESEARCH DEVELOPMENT LTD0 个研究点目标入组 91 人开始时间: 2006年8月3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）
- 发起方
- 入组人数
- 91
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
- •- Histologically confirmed infiltrating primary breast cancer of 2.0 cm in largest clinical diameter - ER and/or PgR positive cancer 10 of positive cancer cell assessed by IHC - Postmenopausal status, defined by at least one of the following 61619; 60 years of age 60 years of age and amenorrheic for 61619; 12 months prior to day 1 60 years of age and amenorrheic for 12 months prior to day, or without a uterus luteinizing hormone LH and follicle stimulating hormone FSH values within postmenopausal range Prior bilateral oophorectomy Prior radiation castration with amenorrhea for at least 6 months - HER2 negative tumors IHC 0-2 , or FISH negative - Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment - Age over 18 years - ECOG PS 0-1 - Normal organ and marrow function as defined below leukocytes 61472;3000/ 61549;L absolute neutrophil count 61472;1,500/ 61549;L platelets 61472;100,000/ 61549;L total bilirubin within normal institutional limits AST SGOT /ALT SGPT 2.5 X institutional upper limit of normal Creatinine within normal institutional limits - Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan. - Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator. A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided in Section 3.7.4.2 Other concomitant treatments. - Ability to understand and the willingness to sign a written informed consent document. - Ability to swallow and retain oral medication.
- •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
- •- Stage IIIB, IIIC, and inflammatory breast cancer - Stage IV breast cancer - Contraindication to the treatment with letrozole - Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with EGFR targeting therapies - Treatment with any other investigational agents, or with all herbal alternative medicines - History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib - Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - HIV-positive patients receiving combination anti-retroviral therapy - GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease e.g., Crohn s, ulcerative colitis - Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors See section 3.7.4.2 Other concomitant treatments
研究者
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