A Pilot Feasibility Study to Evaluate the Efficacy of Lapatinib in Eliminating Cytokeratin-positive Tumour Cells Circulating in the Blood of Women With Breast Cancer
Breast cancer is considered a systemic disease since early tumour cell dissemination may
occur even in patients with small tumours; several investigators using immunocytochemistry
or real time PCR (RT-PCR) have shown that cytokeratin-positive epithelial cells could be
identified in the bone marrow aspirates or the peripheral blood of otherwise metastases-free
patients with stage I and II breast cancer. The clinical importance of the
immunocytochemical detection of occult tumour cells in the bone marrow has been confirmed in
many prospective studies to represent an independent predictive and prognostic factor for
distant relapse and reduced survival.
Patients with metastatic breast cancer who have persistent detection of tumour cells in the
peripheral blood (≥5 cells/7.5 ml) despite at least one line of chemotherapy will receive
lapatinib for a minimum of one month unless disease progression occurs at an earlier time
point.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of lapatinib by quantitative analysis of circulating tumour cells in the blood.The efficacy will be measured before, during and after the completion of treatment
2 months
No
Sofia Aggelaki, MD
Principal Investigator
University Hospital of Crete
Greece: National Organization of Medicines
CT/07.15
NCT00694252
July 2008
November 2011
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