Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer

PRIMARY OBJECTIVES:

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 metastasis.

SECONDARY OBJECTIVES:

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
(TGF)-beta levels.

OUTLINE:

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
unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 4, 8, and 12 weeks.

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