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GW572016 In Patients With Advanced Or Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00462956
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment Phase
Neoplasms, Breast Drug: Tykerb Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer
Actual Study Start Date : June 30, 2004
Actual Primary Completion Date : December 20, 2006
Actual Study Completion Date : December 20, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: lapatinib 1500mg daily
Subjects will self-administer lapatinib 1500 mg orally once daily.
Drug: Tykerb
lapatinib 1500mg daily



Primary Outcome Measures :
  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 Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

  • Patients with certain heart problems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462956


Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 802-0077
GSK Investigational Site
Kanagawa, Japan, 241-0815
GSK Investigational Site
Saitama, Japan, 350-1298
GSK Investigational Site
Tochigi, Japan, 320-0834
GSK Investigational Site
Tokyo, Japan, 104-0045
GSK Investigational Site
Tokyo, Japan, 113-8677
GSK Investigational Site
Tokyo, Japan, 135-8550
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00462956     History of Changes
Other Study ID Numbers: EGF100642
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
lapatinib
metastatic breast cancer
trastuzumab (Herceptin)
Stage IV breast cancer
ErbB2
ErbB1

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lapatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action