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

OBJECTIVES:

Primary

• Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate in women with metastatic breast cancer.
• Determine the toxicity profile of this regimen, in terms of incidence and severity of observed toxic effects, in these patients.

Secondary

• Determine the time to disease progression and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive ABI-007 IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 20 months.

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