Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed invasive breast cancer

- Clinical evidence of metastatic disease

+ No bone metastases or other non-measurable disease as the only evidence of
metastasis

- Measurable disease, defined as at least 1 measurable lesion

- The following are considered non-measurable disease:

- Small lesions (< 2 cm)

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusions

- Inflammatory breast disease

- Lymphangitis cutis or pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- HER2(human epidermal growth factor receptor 2)-positive disease allowed provided
patient has received prior treatment with trastuzumab

- No evidence of active brain metastasis, including leptomeningeal involvement

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over Sex

- Female Menopausal status

- Not specified Performance status

- ECOG 0-1 Life expectancy

- At least 12 weeks Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL Hepatic

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

- Bilirubin ≤ 1.5 times ULN Renal

- Creatinine ≤ 1.5 mg/dL Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment

- No pre-existing peripheral neuropathy > grade 1

- No other clinically significant illness or significant medical condition that would
preclude study participation

- No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an
injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or
agents that are chemically similar to study drugs

- No serious medical risk factors involving any of the major organ systems that would
preclude study participation

- No active stage III or IV invasive non-breast malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics Chemotherapy

- No more than 1 prior adjuvant chemotherapy regimen

- No prior chemotherapy for metastatic disease

- At least 6 months since prior adjuvant or neoadjuvant taxane

- More than 2 weeks since prior cytotoxic chemotherapy

- Prior neoadjuvant chemotherapy allowed

- No other concurrent chemotherapy Endocrine therapy

- Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed
Radiotherapy

- Prior radiotherapy to target lesion allowed provided there is evidence of disease
progression after completion of treatment

- More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target
lesion only or single-dose palliative radiotherapy

- No concurrent radiotherapy Surgery

- Not specified Other

- More than 2 weeks since prior investigational drugs

- No concurrent participation in another clinical trial that is studying
investigational procedures or therapies

- Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation
of pain or lytic lesions from breast cancer