Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases
I. To evaluate the safety of chemoimmunotherapy with topical imiquimod and Abraxane in
breast cancer patients with recurrent chest wall disease or cutaneous metastasis.
II. To evaluate the anti-tumor effects of chemoimmunotherapy with topical imiquimod and
Abraxane in breast cancer patients with recurrent chest wall disease or cutaneous
I. To examine whether treatment with chemoimmunotherapy consisting of topical imiquimod and
Abraxane augments endogenous tumor specific immunity.
II. To assess the effect of chemoimmunotherapy on circulating transforming growth factor
Patients receive Abraxane intravenously (IV) over 30 minutes on days 1, 8, and 15 and apply
topical imiquimod to cutaneous lesions once daily (QD) on days 1-4, 8-11, 15-18, and 22-25.
Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or
After completion of study treatment, patients are followed up at 1, 4, 8, and 12 weeks.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Anti-tumor effects of imiquimod as assessed by modified World Health Organization (WHO) criteria
Tumor responses will be determined using the sum of the products of the largest perpendicular dimensions. Target lesions will be evaluated by the following response criteria: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Baseline and then every 4 weeks until week 24
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|