Study of Lapatinib in Breast Cancer Patients With HER-2 Non-amplified Primary Tumors and HER-2 Positive or EGFR Positive Circulating Tumor Cells
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT00820924
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Neoplasms, Breast
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- LAPATINIB — DRUGLAPATINIB 1500MG ORAL DOSE DAILY
Study Details
The underlying biology of the various patterns of metastasis observed in different tumour types remains unclear. The detection and characterization of circulating tumour cells in cancer patients has provided important new information about the progression of metastatic events. This information has important implications for cancer prognosis and therapy. This multicenter open-label study is designed as a two-stage three-outcome phase II trial. The aim is to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours and HER-2 or EGFR positive circulating tumour cells. Evaluation of HER-2 and EGFR status on circulating tumour cells will be performed by the means of the CellSearch equipment (Immunicon, Huntingdon Valley, PA, USA) and FISH method (PathVysion Kit -Abbott Laboratories).
Key Dates
- Start date
- Jun 30, 2008
- Status verified
- Mar 2012
- Primary completion
- Jul 31, 2011
- Completion
- Jul 31, 2011
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: LAPATINIBLAPATINIB 1500MG ORAL ONCE DAILY
Primary Outcome Measure
The efficacy of lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours with HER-2 or EGFR positive circulating tumour cells. [ Time Frame: approx. 6 mos ]