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

Vassilis Georgoulias, Prof. of Internal Medicine-Oncology of Medical Dpt University of Crete0 sitesMarch 17, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
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
Sponsor: Vassilis Georgoulias, Prof. of Internal Medicine-Oncology of Medical Dpt University of Crete
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

March 17, 2008

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Vassilis Georgoulias, Prof. of Internal Medicine-Oncology of Medical Dpt University of Crete

•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:

•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.