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Sponsored by: |
University Hospital of Crete |
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Information provided by: | University Hospital of Crete |
ClinicalTrials.gov Identifier: | NCT00694252 |
This study will evaluate the efficacy of lapatinib in eradicating chemo- resistant tumour cells circulating in the blood of patients with breast cancer
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: Lapatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Lapatinib
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Drug: Lapatinib
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ioannis Athanasakis | +302810392783 | dclintrials@gmail.com |
Greece | |
University Hospital of Crete | |
Heraklion, Greece, 71110 |
Principal Investigator: | Sofia Aggelaki, MD | University Hospital of Crete |
Responsible Party: | University Hospital of Crete ( Sofia Aggelaki ) |
Study ID Numbers: | CT/07.15 |
Study First Received: | June 6, 2008 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00694252 |
Health Authority: | Greece: National Organization of Medicines |
Breast cancer Tykerb Tyverb CTCs |
Skin Diseases Breast Neoplasms Lapatinib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |