First Line Therapy for Patients With Metastatic Breast Cancer

• to determine the toxicity and anti tumor activity of ABI-007 [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
• Complete or Partial Response [ Designated as safety issue: No ]
  Percentage of patients who achieve an objective confirmed or partial overall response based on the RECIST response criteria

• Disease Control [ Designated as safety issue: No ]
  Percentage of participants with stable disease for > or + 16 weeks, or complete or partial overall response
• Progression-free survival [ Designated as safety issue: No ]
  Number of participants who survive without disease progression
• Duration of response [ Designated as safety issue: No ]
  Duration of response
• Survival [ Designated as safety issue: No ]
  Number of participants alive or dead
• Adverse events [ Designated as safety issue: Yes ]
  Number of participants with adverse events

The purpose of this study is to determine the toxicity and anti-tumor activity of ABI-007 100mg/m^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of their adjuvant therapy.

Inclusion Criteria:

• Females with pathologically confirmed adenocarcinoma of the breast.
• No prior chemotherapy for metastatic breast cancer
• At least 12 months between completion of adjuvant chemotherapy and the diagnosis of metastatic disease
• Stage IV disease
• Measurable disease (must be equal or greater to 2.0cm using conventional CT or equal or greater to 1.0 cm using spiral CT except for pulmonary lesions that are well documented on conventional CT scan which must be equal or greater than 1.0 cm)
• At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be radiologic or clinical exam proof of progressive disease within the radiation portal
• At least 4 weeks since major surgery, with full recovery
• ECOG performance status 0-2
• Age equal or greater to 18
• Patients has the following blood counts at Baseline:
• ANC equal or greater to 1.5 x 10^9 cells/L
• Platelets equal or greater to 100 x 10^9 cells/L
• Hgb equal or greater to 90 grams/L
• Patients has the following blood chemistry levels at Baseline:
• AST (SGOT), ALT (SGPT)less than or equal to 2.5x upper limit of normal range (ULN);
• total bilirubin normal (unless bilirubin elevation is due to Gilbert's (Disease);
• alkaline phosphatase less than or equal 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis);
• creatinine less than or equal to 1.5mg/dL
• Current sensory neuropathy Grade 0 or 1 by BCI CTCAE
• If female of childbearing potential, pregnancy test is negative (within 72 hours of the first dose of study drug).
• If fertile, the patient agrees to use an effective method of contraception to avoid pregnancy for the duration of the study
• Patient is able to supply unstained slides or 1 tumor block of her primary breast tumor or a biopsy of a current site of metastasis for SPARC analysis
• Informed consent has been obtained

Exclusion Criteria:

• Concurrent immunotherapy or hormonal therapy (other than Herceptin) for breast cancer
• Parenchymal brain metastases, unless 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 class II-IV congestive heart failure
• History of other malignancy within the last 5 years which could affect the diagnoses or assessment of breast cancer, with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Patients who have received an investigational drug within the previous 3 weeks
• Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also a patient may not enroll in such clinical trials while participating in this study.
• Pregnant or nursing women
• Patients with prior hypersensitivity to Taxol or Taxotere