Relapsed or refractory infammatory breast cancer (IBC) MedDRA version: 8.1 Level: LLT Classification code 10021974 Term: Inflammatory breast cancer
Conditions
Interventions
Product Name: Lapatinib
Product Code: GW572016
Pharmaceutical Form: Coated tablet
CAS Number: 388082-78-8
Current Sponsor code: GW572016
Sponsors
GlaxoSmithKline R&D Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed breast carcinoma with clinical diagnosis of IBC - Documented disease progression or relapse following treatment, which must have included a taxane and anthracycline-containing regimen in the adjuvant or metastatic setting (30 patients) plus trastuzumab (90 patinets) - Tumour that overexpresses ErbB2 as 3+ by IHC or FISH-positive. The ErbB2 expression status must be documented prior to dosing. - Must have life expectancy of at least 12 weeks - Tumour to be accessible for biopsy - Measureable disease by RECIST or clinically evaluable skin disease - 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 - Recovered or stabilised from effects of previous chemotherapy, surgery or radiotherapy - Have adequate bone marrow function, and renal and hepatic function - Have left ventricular ejection fraction greater than or equal to 50%, or above lower limit of normal for the institution - 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
Exclusion criteria
Exclusion criteria: - Female who is pregnant or lactating - Patient who has malabsorption syndrome, disease affecting GI function, or resection of the stomach or small bowel - Evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease. Patients with brain metastases treated by surgery and/or radiotherapy are eligible if neurologically stable and do not require steroids or anticonvulsants. - Considered medically unfit by the investigator - Has known hypersensitivity reaction or idiosyncrasy to drugs chemically-related to the IMP - Received treatment with any investigational drug in previous 4 weeks - Has received chemotherapy, immunotherapy, biologic therapy or hormonal therapy within the past 14 days (except mitomycin C within past 6 weeks) - Currently receiving amiodarone or within 6 months prior to screening - Currently receiving oral steroid treatment, or any other protocol-specified prohibited medication - Has condition/s which will not permit compliance with the protocol - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of objective response rate (complete response + partial response) to lapatinib treatment in patients with relapsed or refractory IBC whose tumours overexpress ErbB2 ; Secondary Objective: - Evaluate other measures of anti-tumour activity - Assess safety and tolerability of study treatment - Investigate pharmacodynamic effects of study treatment on intracellular biomarkers - Assess the effects of study treatment on proteomic profile and blood levels of extracellular domains of the ErbB1 and ErbB2 receptors - To examine use of FDG-PET as an early predictor of response to study treatment - Pharmacogenetic investigation/s ;Primary end point(s): Assessment of Objective Response Rate (defined as Complete Response plus Partial Response) | — |
Countries
Belgium, Spain, United Kingdom
Outcome results
None listed