Phase II Evaluation of Imiquimod, a Topical Toll-like Receptor 7 (TLR7) Agonist in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
TLR agonists are novel agents for cancer therapy which modify the immune response.
Imiquimod, a synthetic TLR7 agonist has proven immunomodulatory activity when applied
topically, leading to clearance of human papilloma virus (HPV)-induced genital warts and
primary skin malignancies. Its effects will now be examined in breast cancer metastatic to
the skin. If effective, it will add a relatively non-toxic approach to the treatment
armamentarium for this patient population frequently resistant to conventional therapies.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response (Complete Clinical Response+ Partial Response)
This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.
Sylvia Adams, MD
New York University School of Medicine
United States: Institutional Review Board
|NYU Cancer Institute||New York, New York 10016|