A Phase II study to evaluate the efficacy, safety and pharmacodynamics of lapatinib in combination with paclitaxel as neoadjuvant therapy in patients with newly diagnosed inflammatory breast cancer - Lapatinib combined with paclitaxel in newly diagnosed inflammatory breast cancer (IBC)

GlaxoSmithKline R&D Ltd0 个研究点目标入组 60 人开始时间: 2005年6月14日最近更新: 2013年7月15日

适应症

试验速览

暂无简介。

•- Histologically confirmed breast carcinoma with clinical diagnosis of IBC
•- Tumour that:-
•Cohort A - overexpresses ErbB2 (defined IHC 2+ or 3+, or FISH-positive) with or without expression of ErbB1 (by IHC), or
•Cohort B - expression of ErbB1 (defined as IHC +) without overexpression of ErbB2.
•ErbB1 and ErbB2 status must be documented prior to dosing.
•- Tumour that is accessible for multiple biopsies
•- Male or female at least 18 years of age
•- Female patients must either be of non-childbearing potential, or if of childbearing potential to have negative serum pregnancy test at screening and to agree to a protocol-specified method of contraception during participation in the study
•- Able to swallow and retain oral medication
•- ECOG performance status 0-2
•- Have adequate bone marrow function, and renal and hepatic function
•- Have left ventricular ejection fraction greater than or equal to 50% based on ECHO or MUGA scan
•- Provide written informed consent
•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

•- Received prior biological, cytotoxic or hormonal therapy for breast cancer
•- Female who is pregnant or lactating
•- Patient who has malabsorption syndrome, disease affecting GI function, or resection of the stomach or small bowel
•- Considered medically unfit by the investigator
•- Has known hypersensitivity reaction or idiosyncrasy to drugs chemically-related to the IMPs
•- Received treatment with any investigational drug in previous 4 weeks
•- Currently receiving amiodarone or within 6 months prior to screening
•- Currently receiving oral steroid treatment, or any other protocol-specified prohibited medication. Use of cimetidine and/or steroids is permitted when required as standard treatment for paclitaxel administration.
•- Had major surgery within previous 2 weeks
•- Has condition/s which will not permit compliance with the protocol
•- Has peripheral neuropathy >= Grade 2
•- Has Class II-IV heart failure (by NYHA classification system)
•- Has a clinically significant ECG abnormality
•- Has inadequate venous access for protocol-related blood sampling.

发起方

GlaxoSmithKline R&D Ltd