Status:
COMPLETED
Lapatinib and Circulating Tumor Cells in Breast Cancer
Lead Sponsor:
University Hospital of Crete
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy of lapatinib in eradicating chemo- resistant tumour cells circulating in the blood of patients with breast cancer.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Provision of written informed consent
- Histologically or cytologically confirmed breast cancer
- Metastatic breast cancer (stage IIIB and IV). EGFR and/or HER-2 expression on the primary tumor is not mandatory.
- Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. Prior hormonal therapy is allowed.
- Patients should have achieved objective response (CR or PR) or stable disease to previous first or second line treatment.
- There should be at least one month between the end of chemotherapy treatment and trial entry. In case of prior Herceptin administration, 3 months are required to have elapsed before study entry.
- Detection of ≥5 cells/7.5ml of peripheral blood detected by Cell Search System despite the previous administration of chemotherapy and/or hormonal therapy.
- HER-2 expression on CTCs.
- Age 18 years and over
- Adequate Haematological function, Absolute neutrophil count ≥1.5 x 109/L, Platelet count ≥100 x 109/L and Haemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level)
- Adequate Liver Function, total bilirubin \<1.5 x upper limit of normal, AST and ALT \<2.5 x upper limit of normal in patients without liver metastases and \<5 x upper limit of normal in patients with liver metastases
- Adequate Renal function, Serum creatinine ≤1.25 x upper limit of normal or calculated creatinine clearance ≥50 mL/min
- LVEF within institutional normal range
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 12 weeks
Exclusion
- Any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity greater than Grade 2 (NCI- CTCAE) from previous anticancer therapy (except alopecia)
- Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
- Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
- Known hypersensitivity to drugs chemically related to lapatinib
- Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00694252
Start Date
July 1 2008
End Date
November 1 2011
Last Update
September 28 2015
Active Locations (1)
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1
University Hospital of Crete
Heraklion, Greece, 71110