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CompletedNCT00462956Updated Aug 31, 2018

GW572016 In Patients With Advanced Or Metastatic Breast Cancer

A Phase 1 interventional study of Tykerb in Neoplasms, Breast, sponsored by GlaxoSmithKline. Completed at 9 sites in Japan. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-08-31.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Jun 2004, registered Apr 2007).
Phase
Phase 1
Study type
Interventional
Enrollment
59
Allocation
Non-randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.

02

Conditions studied

  • Neoplasms, Breast

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Keywords

  • lapatinib
  • metastatic breast cancer
  • trastuzumab (Herceptin)
  • Stage IV breast cancer
  • ErbB2
  • ErbB1
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 59 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients.
  • Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
  • Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion criteria

Exclusion Criteria:

  • Patients with certain heart problems.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    lapatinib 1500mg daily

    Subjects will self-administer lapatinib 1500 mg orally once daily.

    Drug: Tykerb

Interventions

  • DrugTykerb

    lapatinib 1500mg daily

06

What researchers measure

Primary outcomes

  1. To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016

Secondary outcomes

  1. Clinical benefitTime to tumor responseLength of responseTime to progression of cancer4 and 6 month progression free survivalOverall survival as well as specific biomarkers in tumor tissue

07

Study locations

9 sites
  • GSK Investigational Site
    Ehime, 791-0280, Japan
  • GSK Investigational Site
    Fukuoka, 802-0077, Japan
  • GSK Investigational Site
    Kanagawa, 241-0815, Japan
  • GSK Investigational Site
    Saitama, 350-1298, Japan
  • GSK Investigational Site
    Tochigi, 320-0834, Japan
  • GSK Investigational Site
    Tokyo, 104-0045, Japan
  • GSK Investigational Site
    Tokyo, 113-8677, Japan
  • GSK Investigational Site
    Tokyo, 135-8550, Japan
  • GSK Investigational Site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00462956
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 19, 2007
Start date
Jun 30, 2004
Primary completion
Dec 20, 2006
Completion
Dec 20, 2006
Last update
Aug 31, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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