Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer
This is a single center, open phase I dose escalation study. This study will assess the
highest tolerable dose of nab-paclitaxel (Abraxane) in combination with doxorubicin
(Adriamycin) and cyclophosphamide in patients with stages II-III breast cancer in the
neoadjuvant setting. The objective is to primarily assess the safety of the drug
combination, and to secondarily obtain preliminary data on the clinical efficacy of the
combination. Up to 24 patients will be enrolled.
The study will test four dose levels of Abraxane as described in Table 2, with fixed dose of
doxorubicin (50 mg/m2 weekly) and cyclophosphamide (500 mg/m2). For each cycle, Abraxane
will be administered based on the dose schedule in Table 2. Adriamycin and Cyclophosphamide
will be given on day 1 and day 22 of each cycle. Each cycle will be repeated every 6 weeks.
The study will enroll patients with stages II-III, Her-2 negative breast cancer with no
prior therapy. Patients will be treated for 3 six-week cycles, for a total of 18 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities
Hung Khong, MD
University of Utah
United States: Institutional Review Board
|University of Utah Huntsman Cancer Institute||Salt Lake City, Utah 84112|