Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer
Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
OBJECTIVES:
Primary
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:
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:
PATIENT CHARACTERISTICS:
Age
PRIOR CONCURRENT THERAPY:
Biologic therapy
Thorton, Colorado 80229, United States
Honolula, Hawaii 96813, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
West Des Moines, Iowa 50266, United States
Wichita, Kansas 67214, United States
Ann Arbor, Michigan 48106-0995, United States
Grosse Pointe Woods, Michigan 48236, United States
Lambertville, Michigan 48144, United States
Lichfield, Minnesota 55355, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Wright-Patterson AFB, Ohio 45433-5529, United States
Allentown, Pennsylvania 18105, United States
Wilkes-Barre, Pennsylvania 18711, United States
Anderson, South Carolina 29621, United States
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Sioux Falls, South Dakota 57117-5039, United States