Phase I/II Study of TLR7 Agonist Imiquimod and Radiotherapy in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
1. Patients with biopsy-confirmed breast cancer.
2. Patients with measurable skin metastases and distant, measurable metastases (outside
of skin) by RECIST. For patients without distant measurable metastases, an area of
the skin metastases designated to not receive local therapy can be substituted.
3. Age >= 18 years.
4. ECOG performance status 0-2.
5. Patients must agree to tumor FNA required by protocol.
6. Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) can be
continued if distant metastases are non-responsive (i.e. no CR or PR) on that regimen
for >= 8 weeks as assessed by the investigator.
7. Patients must have adequate organ and bone marrow function as defined below:
- absolute neutrophil count >= 1,300/microliter
- hemoglobin >= 9.0 grams/deciliter
- platelets >= 75,000/microliter
- total bilirubin =< 1.5 X institutional upper limit of normal
- AST =< 2.5 X institutional upper limit of normal
- ALT < 2.5 X institutional upper limit of normal
- creatinine =< 1.5 X institutional upper limit of normal
8. Informed consent.
1. Brain metastases unless resected or irradiated and stable >= 4 weeks.
2. Concurrent treatment with other investigational agents.
3. Patients who have received any local therapy (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.
4. Patients who have received hyperthermia to the target area within 10 weeks prior to
first dosing of study agent.
5. Patients with an uncontrolled bleeding disorder.
6. 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.
7. Patients with known immunodeficiency or receiving immunosuppressive therapies.
8. History of allergic reactions to imiquimod or its excipients.
9. Uncontrolled intercurrent medical illness or psychiatric illness/social situations
that would limit compliance with study requirements.
10. Pregnancy or lactation.
11. Women of childbearing potential not using a medically acceptable means of