An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens
- Signed Informed Consent.
- Histologically confirmed Stage IIIb or IV breast cancer.
- Refractory breast cancer defined as progression in the metastatic setting after prior
therapy with anthracyclines, taxanes and capecitibine.
- Subjects with documented ErbB2 tumor overexpression must have received at least 6
cycles of trastuzumab.
- Documented disease progression of the most recent treatment is required.
- Archived tumor tissue available for testing.
- Measurable lesions according to Response Evaluation Criteria In Solid Tumors
- At least 3 weeks since prior cancer therapies except for trastuzumab which must be
discontinued at least 2 weeks prior to the beginning of study drug.
- Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation
of bisphosphonates following study entry is not allowed.
- Able to swallow and retain oral medication.
- Cardiac ejection fraction within the institutional normal range as measured by
echocardiogram or MUGA (Multiple Gated Acquisition) scan.
- Adequate kidney and liver function.
- Adequate bone marrow function.
- Pregnant or lactating.
- Copies of nadir scans and/or photographs of the tumor prior to disease progression as
well as scans documenting disease progression are not available for review.
- Malabsorption syndrome, ulcerative colitis, disease significantly affecting
gastrointestinal function or resection of the stomach or small bowel.
- History of other malignancy.
- Serious medical or psychiatric disorder that would interfere with the patient''s
safety or informed consent.
- Active or uncontrolled infection.
- Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart
- Known history of or clinical evidence of leptomeningeal carcinomatosis.
- Active infection.
- Concurrent cancer therapy or investigational therapy.
- Use of oral or IV steroids.
- Unresolved or unstable serious toxicity from prior therapy.
- Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.