A pilot feasibility study to evaluate the efficacy of lapatinib in eliminating cytokeratin-positive tumor cells circulating in the blood of women with brest cancer

• Conditions: Metastatic breast cancer patients with detectable circulating tumor cells in peripheral blood (>=5 cells/7.5 ml) even after administration of at least one chemotherapy regimen

• Registration Number: EUCTR2007-005400-40-GR
• Lead Sponsor: Vassilis Georgoulias, Prof. of Internal Medicine-Oncology of Medical Dpt University of Crete

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-17
• Last Update Posted: 14 July 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Provision of written informed consent
2.Histologically or cytologically confirmed breast cancer
3.Metastatic breast cancer (stage IIIB and IV). EGFR and/or HER-2 expression on the primary tumor is not mandatory.
4.Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. Prior hormonal therapy is allowed.
5.Patients should have achieved objective response (CR or PR) or stable disease to previous first or second line treatment.
6.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.
7.Detection of =5 cells/7.5ml of peripheral blood detected by Cell Search System (Veridex) despite the previous administration of chemotherapy and/or hormonal therapy.
8.HER-2 expression on CTCs.
9.Age 18 years and over Adequate organ function
Haematological function:
•Absolute neutrophil count (ANC) =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)

Liver Function:
•Total bilirubin <1.5 x upper limit of normal (ULN)
•AST, ALT <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases

Renal function:
•Serum creatinine =1.25 x ULN or calculated creatinine clearance =50 mL/min

10.LVEF within institutional normal range
11.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
12.Life expectancy of at least 12 weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
2.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
3.Any unresolved chronic toxicity greater than Grade 2 (NCI- CTCAE) from previous anticancer therapy (except alopecia)
4.Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
5.Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
6.Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
7.Known hypersensitivity to drugs chemically related to lapatinib
8.Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.
9.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
10.Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors complications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy evaluation of lapatinib in elimination of chemo-resistant circulating tumor cells of breast cancer patients;Secondary Objective: - Correlation of CTCs level with Progression Free Survival (PFS)<br>- Safety evaluation of lapatinib administration in this patient population;Primary end point(s): The efficacy of lapatinib will be measured by quantitative analysis of circulating tumour cells in the blood before, during and after the completion of lapatinib treatment. These cells will be detected using the CellSearch System (Veridex).