Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer
Condition: Male Breast Cancer; Recurrent Breast Cancer; Skin Metastases; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Breast Neoplasms, Male
Intervention: imiquimod; Abraxane; laboratory biomarker analysis; RNA analysis; immunoenzyme technique
Intervention description: Given topically; Given IV; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Imiquimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Stage IV; cream; topical

Summary:

      This phase II trial is studying the side effects of giving topical imiquimod together with
      Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) to see how well it works in
      treating patients with advanced breast cancer. Biological therapies, such as imiquimod, may
      stimulate the immune system to kill tumor cells. Drugs used in chemotherapy, such as
      Abraxane, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving imiquimod together with Abraxane may kill
      more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with advanced stage refractory breast cancer

          -  Progressive or relapsed disease following standard therapy with chemotherapy and/or
             surgery, and/or radiation

          -  Patients must have measurable (bi-dimensional) chest wall disease and/or cutaneous
             metastatic lesions

          -  Patients must be at least 7 days from last chemotherapy and 30 days from local
             radiotherapy and/or systemic steroids

          -  Patients on bisphosphonates, trastuzumab, lapatinib and/or hormonal therapy are
             eligible

          -  White blood cell count >= 1000/ul

          -  Absolute neutrophil count (ANC) >= 1200/ul

          -  Platelets > 75,000/ul

          -  Serum creatinine =< 2.0 mg/dL, a creatinine clearance > 60 ml/min

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 X upper limit
             normal (ULN)

          -  Total bilirubin < 2 X ULN

          -  Patients must have a Performance Status Score (Eastern Cooperative Oncology Group
             [ECOG] Scale) =< 2

          -  Patients must have recovered from major infections and/or surgical procedures and, in
             the opinion of the investigator, not have a significant active concurrent medical
             illness precluding protocol treatment

          -  Men and women of reproductive ability must agree to contraceptive use during the study
             and for 1 month after imiquimod/Abraxane treatment is discontinued

        Exclusion Criteria:

          -  Patients with prior allergic reaction to taxanes

          -  Patients with any clinically significant active autoimmune disease requiring active
             treatment with systemic steroids or other immunomodulators

          -  Pregnant or breast-feeding women

          -  Patients with peripheral neuropathy >= Grade 2