Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
Condition: Breast Cancer; Breast Neoplasms
MeSH terms: Breast Neoplasms; Recurrence
Intervention: Imiquimod
Intervention description: Each treatment cycle consists of 8 weeks.
Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.
Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.
Intervention MeSH terms: Imiquimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: toll-like receptor; toll-like receptor agonist; recurrent breast cancer; breast cancer metastasized to skin and/or chestwall; immunomodulator

Summary:

      The purpose of this trial is to determine the safety and efficacy of Imiquimod, a Toll-like
      receptor 7 agonist in breast cancer (for chestwall recurrences or metastases to the skin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with biopsy-confirmed breast cancer (prior histological documentation is
             acceptable).

          -  Patients with measurable skin metastases (chest wall recurrence and/or non-chest wall
             skin metastases are eligible).

          -  Skin metastases not suitable for or patient refusing definitive surgical resection and
             radiation.

          -  (Cohort 1) Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) is
             allowed if distant metastases have been non-progressing (stable or responding) on that
             regimen for > or = 12 weeks and skin metastases are non-responsive (stable or
             progressing) as assessed by the investigator.

        (Cohort 2) Any concurrent systemic therapy is allowed

          -  Age at least 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.

          -  Patients must have biopsy-accessible tumor (skin metastases) and agree to biopsies
             required by protocol.

          -  Patients must have adequate organ and bone marrow function as defined below:

               -  absolute neutrophil count > or = 1,500/microliter

               -  hemoglobin > or = 9.5 grams/deciliter

               -  platelets >or = 75,000/microliter

               -  total bilirubin < or = 1.5 X institutional upper limit of normal

               -  Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < or = 2.5X
                  institutional upper limit of normal

               -  creatinine < or = 1.5 X institutional upper limit of normal

          -  Informed consent.

        Exclusion Criteria:

          -  Brain metastases unless resected or irradiated and stable > or = 8 weeks.

          -  Treatment with other investigational agents.

          -  Patients who have received radiotherapy, high-potency corticosteroids, intralesional
             therapy, laser therapy or surgery other than biopsy to the target area within 4 weeks
             prior to first dosing of study agent.

          -  Patients who have received hyperthermia to the target area within 10 weeks prior to
             first dosing of study agent.

          -  Patients with an uncontrolled bleeding disorder.

          -  Patients who will be therapeutically anticoagulated with heparins or coumadin at the
             time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy
             as per investigator). Patients on aspirin and other platelet agents are eligible.

          -  Patients with known immunodeficiency or receiving immunosuppressive therapies.

          -  History of allergic reactions to imiquimod or its excipients.

          -  Uncontrolled intercurrent medical illness or psychiatric illness/social situations
             that would limit compliance with study requirements.

          -  Pregnancy or lactation.

          -  Women of childbearing potential not using a medically acceptable means of
             contraception.