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

GlaxoSmithKline Reseacrh and Development Limited0 个研究点目标入组 120 人开始时间: 2007年6月27日最近更新: 2016年3月14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;
•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 the use by the Principial Investigator.
•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 121
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•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 Reseacrh and Development Limited