GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371488
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : August 31, 2018
Information provided by (Responsible Party):

Brief Summary:
This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.

Condition or disease Intervention/treatment Phase
Neoplasms, Breast Drug: GW572016 oral tablets Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Lapatinib in Combination With Trastuzumab
Actual Study Start Date : April 6, 2006
Actual Primary Completion Date : December 10, 2007
Actual Study Completion Date : December 10, 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: GW572016 in combination with trastuzumab


A specified dose of lapatinib will be orally taken once daily, at least one hour before or one hour after the morning meal. Lapatinib should be taken at the same time of day wherever possible.

The starting dose of lapatinib should be 750 mg/day, which will be increased to 1000 mg/day (dose escalation group) according to the dose escalation criteria.


Trastuzumab (4 mg/kg/day in the first week and 2 mg/kg/day for the 2nd and subsequent weeks) will be administered by intravenous infusion over at least 90 minutes immediately after administration of lapatinib. The fifth (Day 36) and subsequent doses may be administered up to 3 days after the scheduled date. In this case, however, the all following doses should be administered at one-week intervals.

Drug: GW572016 oral tablets
Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet. Oval, orange, film-coated tablets.

Primary Outcome Measures :
  1. Optimal doses and toleration of the two drugs administered together Tumor progression measured by radiological imaging 4-8 weekly [ Time Frame: 6 Months ]
    To confirm the safety and tolerability of the recommended dose of lapatinib in combination with trastuzumab which was determined in a preceding overseas study, and to determine the recommended dose in Japan.

Secondary Outcome Measures :
  1. Clinical benefit Time to tumor response Length of response Time to progression of cancer 6 month progression free survival Overall survival as well as specific biomarkers in tumor tissue [ Time Frame: 6 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Patients with confirmed breast cancer who have received prior trastuzumab.
  • 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 identifier (NCT number): NCT00371488

GSK Investigational Site
Saitama, Japan, 350-1298
GSK Investigational Site
Tokyo, Japan, 135-8550
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: GlaxoSmithKline Identifier: NCT00371488     History of Changes
Other Study ID Numbers: EGF105635
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by GlaxoSmithKline:
Stage IV breast cancer
breast cancer

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