Study of Lapatinib in Breast Cancer Patients With HER-2 Non-amplified Primary Tumors and HER-2 Positive or EGFR Positive Circulating Tumor Cells

NCT00820924 | Terminated Phase 2

• 1 other identifier: 105594
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 10

Brief Summary

The underlying biology of the various patterns of metastasis observed in different tumour types remains unclear. The detection and characterization of circulating tumour cells in cancer patients has provided important new information about the progression of metastatic events. This information has important implications for cancer prognosis and therapy. This multicenter open-label study is designed as a two-stage three-outcome phase II trial. The aim is to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours and HER-2 or EGFR positive circulating tumour cells. Evaluation of HER-2 and EGFR status on circulating tumour cells will be performed by the means of the CellSearch equipment (Immunicon, Huntingdon Valley, PA, USA) and FISH method (PathVysion Kit -Abbott Laboratories).

Conditions

Neoplasms, Breast

Keywords

HER-2; Circulating Tumour Cell (CTC); EGFR; Lapatinib (GW572016); Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The efficacy of lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours with HER-2 or EGFR positive circulating tumour cells.

  approx. 6 mos

Secondary Outcomes (3)

• Antitumour activity of lapatinib

  approx. 6 mos

• Safety of lapatinib as measured by number of AEs

  approx. 6 mos

• Early response of lapatinib on proliferation and the MAP kinase cascade by PET in a substudy in patients with EGFR positive CTCs only.

  approx. 6 mos

Study Arms (1)

LAPATINIB

EXPERIMENTAL

LAPATINIB 1500MG ORAL ONCE DAILY

Drug: LAPATINIB

Interventions

LAPATINIB DRUG

LAPATINIB 1500MG ORAL DOSE DAILY

LAPATINIB

Eligibility Criteria

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

You may qualify if:

• Female patients at least 18 years old with HER-2 negative breast cancer.
• Patients must have evidence of HER-2 or EGFR positive circulating tumour cells in a peripheral blood sample taken at screening visit.
• Patients must have measurable, metastatic disease and no brain metastasis requiring local therapy.
• Other criteria include ECOG score 0 to 2, life expectancy \> 12 weeks, baseline organ function at screening visit,
• Previous treatment with anthracyclines and/or taxanes in the neo-adjuvant, adjuvant or advanced setting, and at least one line of treatment for metastatic disease.

You may not qualify if:

• Unstable medical conditions, pregnant or lactating women.
• Inability to provide informed consent.
• Lack of physical integrity of the upper gastrointestinal (GI) tract.
• Co-existing malignancy or malignancies within the last 5 years with the exception of basal cell carcinoma or in-situ carcinoma, concurrent anti-cancer therapies (chemo or hormonal therapy) or investigational drugs other than study drug.
• Concurrent radiotherapy to the only target lesion or concurrent bisphosphonates if bone metastases are the only target lesions.
• Previous treatment with anti HER-2 or anti-EGFR therapies.
• Protocol specified treatment regimens that would be inappropriate for the management of the subject.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Rimini, Emilia-Romagna, 47900, Italy

Location

GSK Investigational Site

Udine, Friuli Venezia Giulia, 33100, Italy

Location

GSK Investigational Site

Bergamo, Lombardy, 24128, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20121, Italy

Location

GSK Investigational Site

Rozzano (MI), Lombardy, 20089, Italy

Location

GSK Investigational Site

Livorno, Tuscany, 57124, Italy

Location

GSK Investigational Site

Prato (PO), Tuscany, 59100, Italy

Location

GSK Investigational Site

Perugia, Umbria, 06156, Italy

Location

GSK Investigational Site

Ancona, 60020, Italy

Location

GSK Investigational Site

London, W6 8RF, United Kingdom

Location

Related Publications (2)

• Stebbing J, Payne R, Reise J, Frampton AE, Avery M, Woodley L, Di Leo A, Pestrin M, Krell J, Coombes RC. The efficacy of lapatinib in metastatic breast cancer with HER2 non-amplified primary tumors and EGFR positive circulating tumor cells: a proof-of-concept study. PLoS One. 2013 May 7;8(5):e62543. doi: 10.1371/journal.pone.0062543. Print 2013.

  PMID: 23667487 DERIVED

• Pestrin M, Bessi S, Puglisi F, Minisini AM, Masci G, Battelli N, Ravaioli A, Gianni L, Di Marsico R, Tondini C, Gori S, Coombes CR, Stebbing J, Biganzoli L, Buyse M, Di Leo A. Final results of a multicenter phase II clinical trial evaluating the activity of single-agent lapatinib in patients with HER2-negative metastatic breast cancer and HER2-positive circulating tumor cells. A proof-of-concept study. Breast Cancer Res Treat. 2012 Jul;134(1):283-9. doi: 10.1007/s10549-012-2045-1. Epub 2012 Apr 4.

  PMID: 22476856 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

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 12, 2009
• Study Start: June 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 28, 2012

Record last verified: 2012-03

Locations

GB (1); IT (9)