A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination With Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer

Inclusion Criteria

Inclusion criteria:

- Signed Informed Consent

- Able to swallow an oral medication

- Cardiac ejection fraction within the institutional range of normal as measured by
echocardiogram

- Adequate kidney and liver function

- Adequate bone marrow function

- Tumor tissue available for testing

- Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or
anthracenedione-containing regimen however, subjects must have had cumulative doses
of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of
mitoxantrone

- No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has
never been tested

Exclusion criteria:

- Prior treatment regimens for advanced or metastatic breast cancer.

- Pregnant or lactating

- Conditions that would effect the absorption of an oral drug

- Active infection

- Brain metastases

- Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.

- Known hypersensitivity to Taxol or excipients of Taxol

- Peripheral neuropathy of Grade 2 or greater is not permitted

- Severe Cardiovascular disease or cardiac disease requiring a device.

- Serious medical or psychiatric disorder that would interfere with the patient's
safety or informed consent.