Lapatinib and Circulating Tumor Cells in Breast Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Correlation of the levels of CTCs with the PFS of the patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Assessment of the safety of lapatinib administration in this patient population. [ Time Frame: During treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Patients will receive lapatinib monotherapy 1500 mg/day for a period of at least one month depending on their response and the clinical status of their disease.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694252
|University Hospital of Crete|
|Heraklion, Greece, 71110|
|Principal Investigator:||Sofia Aggelaki, MD||University Hospital of Crete|