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Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer

Phase 1
20 Years
40 Years
Not Enrolling
Neoplasms, Breast

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Trial Information

Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

June 2004

Completion Date:

December 2007

Related Keywords:

  • Neoplasms, Breast
  • lapatinib
  • metastatic breast cancer
  • trastuzumab (Herceptin)
  • Stage IV breast cancer
  • ErbB2
  • ErbB1
  • Breast Neoplasms
  • Neoplasms