ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer

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