Lapatinib and Circulating Tumor Cells in Breast Cancer

NCT00694252 | Completed Phase 2

• 1 other identifier: CT/07.15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

Breast cancer; Tykerb; CTCs

Outcome Measures

Primary Outcomes (1)

• 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

  2 months

Secondary Outcomes (2)

• Correlation of the levels of CTCs with the PFS of the patients

  1 year

• Assessment of the safety of lapatinib administration in this patient population.

  During treatment

Study Arms (1)

1

EXPERIMENTAL

Lapatinib

Drug: Lapatinib

Interventions

Lapatinib DRUG

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.

Also known as: Tykerb, Tyverb, GW572016

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Crete: lead

Study Sites (1)

University Hospital of Crete

Heraklion, 71110, Greece

Location

Related Publications (1)

• Agelaki S, Kalykaki A, Markomanolaki H, Papadaki MA, Kallergi G, Hatzidaki D, Kalbakis K, Mavroudis D, Georgoulias V. Efficacy of Lapatinib in Therapy-Resistant HER2-Positive Circulating Tumor Cells in Metastatic Breast Cancer. PLoS One. 2015 Jun 17;10(6):e0123683. doi: 10.1371/journal.pone.0123683. eCollection 2015.

  PMID: 26083256 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sofia Aggelaki, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. V.Georgoulias

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

GR (1)