Know Cancer

forgot password

Phase II Evaluation of Imiquimod, a Topical Toll-like Receptor 7 (TLR7) Agonist in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases

Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Breast Neoplasms

Thank you

Trial Information

Phase II Evaluation of Imiquimod, a Topical Toll-like Receptor 7 (TLR7) Agonist in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases

TLR agonists are novel agents for cancer therapy which modify the immune response.
Imiquimod, a synthetic TLR7 agonist has proven immunomodulatory activity when applied
topically, leading to clearance of human papilloma virus (HPV)-induced genital warts and
primary skin malignancies. Its effects will now be examined in breast cancer metastatic to
the skin. If effective, it will add a relatively non-toxic approach to the treatment
armamentarium for this patient population frequently resistant to conventional therapies.

Inclusion Criteria:

- Patients with biopsy-confirmed breast cancer (prior histological documentation is

- 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.

Exclusion Criteria:

- Brain metastases unless resected or irradiated and stable > or = 8 weeks.

- Treatment with other investigational agents.

- Patients who have received 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.

- Patients who have received hyperthermia to the target area within 10 weeks prior to
first dosing of study agent.

- Patients with an uncontrolled bleeding disorder.

- 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.

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response (Complete Clinical Response+ Partial Response)

Outcome Description:

This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.

Outcome Time Frame:

9 weeks

Safety Issue:


Principal Investigator

Sylvia Adams, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Institutional Review Board

Study ID:

NYU 09-0225



Start Date:

May 2009

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • toll-like receptor
  • toll-like receptor agonist
  • recurrent breast cancer
  • breast cancer metastasized to skin and/or chestwall
  • immunomodulator
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Recurrence



NYU Cancer Institute New York, New York  10016