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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

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

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

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

Inclusion Criteria:

- 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 Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Sofia Aggelaki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete


Greece: National Organization of Medicines

Study ID:




Start Date:

July 2008

Completion Date:

November 2011

Related Keywords:

  • Metastatic Breast Cancer
  • Breast cancer
  • Tykerb
  • CTCs
  • Breast Neoplasms
  • Neoplastic Cells, Circulating