A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin TM With Herceptin R As First-Line Therapy of Advanced Her-2 Positive Breast Cancer

Inclusion Criteria:

- Confirmed adenocarcinoma of the breast

- Tumor shows 3+ overexpression of the HER-2/proto-oncogene by immunohistochemistry
assay, or is FISH+

- Stage IV disease

- Measurable disease

- At least 3wks since prior cytotoxic chemotherapy

- At least 4wks since radiotherapy with full recovery

- At least 4wks since major surgery with full recovery

- ECOG performance status 0-2

- At least 18yrs old

- ANC at least 1.5 x 10^9 cells/L

- Platelets at least 100 x 10^9 cells/L

- Hemoglobin at least 9 g/dL

- AST, ALT less than 2.5X upper limit normal

- Alkaline Phosphatase less than 1.5X upper limit normal

- Creatinine less than 1.5 gm/dL

- Normal left ventricular ejection fraction

- Negative pregnancy test

- Agree to use method to avoid pregnancy

- Informed Consent is obtained

Exclusion Criteria:

- Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One
year since Taxane and Herceptin treatment.

- Cumulative life-time dose of doxorubicin is greater than 360 mg/m2

- Concurrent immunotherapy or hormonal therapy

- Parenchymal brain metastases, if present, must be documented to be clinically and
radiographically stable for at least 6 months after treatment

- Serious intercurrent medical or psychiatric illness, including serious active
infection

- History of congestive heart failure

- History of other malignancy within the last 5 years which could affect the diagnosis
or assessment of breast cancer

- Patients who have received an investigational drug within the previous 3 weeks

- Patient is currently enrolled in another clinical study receiving investigational
therapies

- Pregnant or nursing women