First Line Therapy for Patients With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: ABI-007
Intervention description: 100 mg/m^2 ABI-007 weekly for 3 weeks followed by 1 week rest
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Breast Cancer, ABI-007, Abraxane

Summary:

      The purpose of this study is to determine the toxicity and anti-tumor activity of
      nab-paclitaxel 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.
    

Eligibility criteria:

        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 2.0 cm using conventional Computed
             Tomography (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

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Age equal or greater to 18

          -  Patients has the following blood counts at Baseline:

          -  Absolute Neutrophil Count (ANC) equal or greater to 1.5 x 10^9 cells/L

          -  Platelets equal or greater to 100 x 10^9 cells/L

          -  Hemoglobin (Hgb) equal or greater to 90 grams/L

          -  Patients has the following blood chemistry levels at Baseline:

          -  Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT),
             alanine aminotransferase (ALT) serum glutamic:pyruvic transaminase (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 Breast Cancer Index (BCI) Common Toxicity
             Criteria Adverse Events (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 Secreted protein acidic and rich
             in cysteine (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