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Phase 1/2 study of TLR7 agonist Imiquimod, Cyclophosphamide, and Radiotherapy in Breast Cancer Patients with Chest Wall Recurrence or Skin Metastases

Clinical Trial Details

This study is open to women who have breast cancer with skin metastases or chest wall metastases. The purpose of this study is to evaluate whether the combinations of radiation therapy with the study drug, Imiquimod (ALDARA TM) preceded by low dose cyclophosphamide, or cyclophosphamide with radiation therapy (if you don't have accessible skin metastases) can induce an immune response against your breast cancer.. Imiquimod and radiation therapy treatments are local treatments given to the skin metastases aimed at boosting your immune response to the cancer, which might then effectively also treat systemic metastases.

Cyclophosphamide is a chemotherapy drug given intravenously (into your vein). Cyclophospamide is available in generic form or under trade names Cytoxan® and Neosar®, and is approved by the Food and Drug Administration (FDA) for use in various diseases including breast cancer. In this study, cyclophosphamide is given at low dose to improve the immune response.

ALDARA™ is topical cream applied directly to the cancer-involved skin. It contains Imiquimod, a Toll-like receptor (TLR) agonist (also called immune response modifier as it helps to boost the immune system to fight off infections and cancer). It is approved by the FDA to treat genital warts related to viruses, actinic keratosis (a type of skin lesion due to sun damage), and superficial basal cell carcinoma (a type of skin cancer).

Radiotherapy is an approved treatment for breast cancer. Radiation therapy is used in this study for its ability to boost the immune system against the cancer, and to boost the immune effects of Imiquimod. and/or cyclophosphamide

Imiquimod has been studied in skin metastases of patients with melanoma (a skin cancer) and in 2 studies of patients with breast cancer with skin metastases. It was well tolerated and has demonstrated to achieve tumor shrinkage in patients with melanoma and breast cancer metastases. However, numbers of patients with these conditions who received ALDARA™ are small and treatment with ALDARA™ remains investigational. Furthermore, the combination of ALRADA™, low dose cyclophosphamide and radiation therapy has not been studied in patients before.

Key Eligibility: 
  • Open to women 18 years or older who have biopsy proven breast cancer
  • Patients with at least one measurable skin metastasis and distant measurable metastasis by RECIST
  • Patients with skin metastases must agree to tumor FNA (biopsy) which is required by the protocol
  • Ability to understand and the willingness to sign a written informed consent document. Patients may not be consented by a durable power of attorney
  • Detailed eligibility will be reviewed when you contact the study team


Sharanya Chandrasekhar

Primary Investigator

Silvia Formenti, M.D.

Protocol ID: 
WCMC IRB #1505016228


Open to Enrollment