Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer

PRIMARY OBJECTIVES: I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2
or higher, need for dose reductions, or delays) of weekly nab-paclitaxel (paclitaxel
albumin-stabilized nanoparticle formulation) in older adults with locally advanced or
metastatic breast cancer.

SECONDARY OBJECTIVES: I. To evaluate the efficacy (response and time to progression) of
weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer using
a stratification factor based on patient age (at least 5 patients age 75 years or older and
no more than 15 patients age 65-70 years).

II. To explore predictors of the need for dose reduction, dose delays, or grade 2-5 toxicity
and neuropathy grade 2 or higher based on a cancer-specific geriatric assessment.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation
intravenously (IV) over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Inclusion Criteria:

- Locally advanced or metastatic breast cancer

- Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth
factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel
alone

- First or second line chemotherapy treatment for metastatic disease

- Karnofsky performance scale (KPS) >= 70%

- Resolution of grade >= 2 toxicity from prior therapy (other than alopecia)

- Peripheral neuropathy =< grade 1

- Absolute neutrophil count >= 1,500/mm^3

- Platelets >= 100,000 cells/mm^3

- Hemoglobin (Hb) >= 9.0 g/dl

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x
institutional upper limit of normal

- Alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present
in the absence of liver metastases

- Bilirubin =< 1.5 mg/dl

- Creatinine clearance (calculated or 24 hour) >= 30 ml/min

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients may not be receiving any other investigational agents

- Untreated central nervous system (CNS) metastases or symptomatic CNS metastases
requiring escalating doses of corticosteroids

- Known history of allergic reactions to paclitaxel

- Presence of any serious or uncontrolled infection

- Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months