Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer
- 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.
- Patients with certain heart problems.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016
GSK Clinical Trials
Japan: Pharmaceuticals and Medical Devices Agency
- Neoplasms, Breast
- metastatic breast cancer
- trastuzumab (Herceptin)
- Stage IV breast cancer
- Breast Neoplasms