Know Cancer

forgot password

Phase I/II Study of TLR7 Agonist Imiquimod and Radiotherapy in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases

Phase 1/Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer

Thank you

Trial Information

Phase I/II Study of TLR7 Agonist Imiquimod and Radiotherapy in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases

This is a single arm, open label Phase I/II clinical trial to treat breast cancer with skin
metastases (chest wall or other sites).

A brief Phase I part is conducted, to allow dose optimization in the event of unanticipated
adverse events (3-3 design). In the Phase II part, efficacy is the primary endpoint.
Twenty five patients will be enrolled to Phase II.

Inclusion Criteria:

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.

Exclusion Criteria:

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

Type of Study:


Study Design:

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

Outcome Measure:

systemic tumor response rates (CR+PR) at the time of best overall response (Ph II)

Outcome Time Frame:

9 weeks from the strat of the treatment

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 11-00598



Start Date:

August 2011

Completion Date:

August 2015

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Cancer
  • Recurrent Breast Cancer
  • radiation therapy
  • combination therapy
  • immunotherapy
  • immune response modifier
  • immunostimulatory
  • immunomodulator
  • Breast Neoplasms
  • Neoplasm Metastasis



New York University Medical Center New York, New York  10016