The purpose of this clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24 patients may be enrolled in this study at the Mitchell Cancer Institute. All patients enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin, and Cyclophosphamide.
This is a single center, open phase I dose escalation study with expansion cohort. The dose escalation part of the study is now closed and the highest tolerable dose of nab-paclitaxel (Abraxane) was assessed to be 100 mg/m2 in combination with doxorubicin (Adriamycin) and cyclophosphamide in patients with stages II-III breast cancer in the neoadjuvant setting. The initial phase I study objective was to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination. 25 patients were enrolled. The expansion cohort will enroll 15 additional patients. The purpose of the expansion cohort is to assess pathological complete response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
IV administered over 30 minutes. 100 mg/m2 on days 1 and 8
50 mg/m2 every 3 weeks
500 mg/m2 given every 3 weeks
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities
Time frame: one year
Pathologic complete response
Time frame: 1 year
Overall clinical response rate (OcRR)
Time frame: one year
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