Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases

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.
• •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.