Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics

Inclusion Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

- Diagnosis of metastatic breast cancer

- Any estrogen receptor, progesterone receptor, or HER-2/neu status allowed as long as
the patient will receive paclitaxel albumin-stabilized nanoparticle formulation alone

- First- or second-line chemotherapy treatment for metastatic disease planned

Exclusion criteria:

- Untreated CNS metastases or symptomatic CNS metastases requiring escalating doses of
corticosteroids

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- WBC ≥ 3,000/mm³

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9.0 g/dL

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastases are present in the
absence of liver metastases)

- Bilirubin ≤ 1.5 mg/dL

- Peripheral neuropathy ≤ grade 1

- Creatinine clearance ≥ 30 mL/min (calculated or 24-hour)

- Negative pregnancy test

- Fertile patients must use effective contraception

- Not pregnant or nursing

- No known history of allergic reactions to paclitaxel

- No serious or uncontrolled infection

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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No ≥ grade 2 toxicity from prior therapy (other than alopecia)

- No taxane for adjuvant therapy or metastatic disease within the past 12 months

- No other concurrent investigational agents

- No other concurrent anticancer therapy