A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(R) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) as Initial Treatment of Patients With Metastatic Breast Cancer

Inclusion Criteria:

- Female patient with histologic diagnosis of breast carcinoma

- Stage IV (M1) disease

- No prior cytotoxic chemotherapy regimen for treatment of metastatic breast cancer

- Adult (18 years of age or older) patients

- Adequate hematologic function (ANC >=1500 cells/mm3 and platelets >100,000/mm3

- Serum creatinine <=2.0 mg/dL

- Total bilirubin <=1.5 mg/dL

- AST/SGOT and ALT/SGPT <=3 times the upper limit of institutional normal values

- PT and PTT within institutional normal range

- ECOG performance status of 0-2

- At least one unidimensionally measurable lesion as defined by RECIST criteria
assessable by radiographic evaluation

- A signed IRB/Ethics Committee approved Informed Consent

- Life expectancy of at least 12 weeks

- Fully recovered from any previous surgery

- A negative pregnancy test prior to study entry if premenopausal

- Agree not to take Vitamin E supplementation while receiving study medication

Exclusion Criteria:

- Any prior taxane-containing chemotherapy including Taxol or Taxotere

- Patients who are pregnant or lactating

- Peripheral neuropathy NCI-CTC grade 2 or greater

- Wide-field radiation, hormonal therapy or trastuzumab within 4 weeks of first dose of
study drug; cytotoxic chemotherapy within 6 months of first dose of study drug

- Treatment with an investigational agent within 4 weeks of first dose of study drug

- Patients with a history of carcinomas of primary sites which can not be distinguished
histologically from metastatic breast carcinoma

- Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of
metastatic breast carcinoma

- Brain metastases

- Active bowel obstruction

- Active, serious infection or other serious medical problems (other than metastatic
breast cancer) likely to impair completion of the study protocol

- Concurrent therapy with known substrates or inhibitors of the cytochrome P450
isoenzymes CYP2C8 or CYP3A4

- Concurrent therapy with warfarin or other coumarin derivatives