Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer
Phase 1
20 Years
40 Years
20 Years
40 Years
Not Enrolling
Female
Neoplasms, Breast
Female
Neoplasms, Breast
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:
Interventional
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:
GlaxoSmithKline
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
EGF100642
NCT ID:
NCT00462956
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
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