Phase II study to evaluate the efficacy, safety and pharmacodynamics of lapatinib in patients with relapsed or refractory inflammatory breast cancer - Lapatinib in relapsed or refractory inflammatory breast cancer (IBC)

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 0

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

- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 ;<br> Secondary Objective: - Evaluate other measures of anti-tumour activity<br> - Assess safety and tolerability of study treatment<br> - Investigate pharmacodynamic effects of study treatment on intracellular biomarkers<br> - Assess the effects of study treatment on proteomic profile and blood levels of extracellular domains of the ErbB1 and ErbB2 receptors<br> - To examine use of FDG-PET as an early predictor of response to study treatment<br> - Pharmacogenetic investigation/s<br> ;Primary end point(s): Assessment of Objective Response Rate (defined as Complete Response plus Partial Response)

Secondary Outcome Measures

Name	Time	Method

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