Chemotherapy plus Lapatinib (GW572016) or Trastuzumab or both in HER2+ Primary Breast Cancer. A Randomized Phase IIb study with Biomarker Evaluation - CHERLOB

GlaxoSmithKline Research and Development Limited0 个研究点目标入组 0 人开始时间: 2007年6月14日最近更新: 2020年10月13日

试验速览

暂无简介。

•Histologically confirmed infiltrating primary breast cancer of > 2.0 cm in largest clinical diameter;
•HER2 positive tumor (either IHC 3+ or FISH+);
•Availability of tumour tissue suitable for biological and molecular examination before starting primary treatment;
•Age > 18, < 65;
•ECOG PS 0-1;
•Normal organ and marrow function;
•Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan;
•Adequate contraception methods for women of child-bearing potential;
•Ability to understand and 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) no
•F.1.3.1 Number of subjects for this age range

•Stage IIIB, IIIC and inflammatory breast cancer;
•Stage IV breast cancer;
•Contraindication to the treatment with antracycline, paclitaxel and/or trastuzumab;
•Prior treatment with chemotherapy, endocrine therapy or radiotherapy, Prior treatment with EGFR targeting therapies;
•Treatment with any other investigational agents or herbal (alternative) medicines;
•History of allergic reactions attributed to compounds of similar chemical or biological composition to lapatinib;
•Uncontrolled intercurrent illness;
•Pregnancy or breastfeeding;
•Women of childbearing potential that refuse to adopt adequate contraceptive measures;
•HIV-positive patient receiving combination antiretroviral therapy;
•GI tract disease;
•Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors;

发起方

GlaxoSmithKline Research and Development Limited