The purpose of this trial is to determine the safety and efficacy of Imiquimod, a Toll-like
receptor 7 agonist in breast cancer (for chestwall recurrences or metastases to the skin).
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Locations near you
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Full eligibility criteria for NCT00899574
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients with biopsy-confirmed breast cancer (prior histological documentation is acceptable).
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
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 contraception.
All locations for NCT00899574
United States (1)
NYU Cancer Institute
New York, New York, United States, 10016
Trial results for NCT00899574
Participant Flow: Overall Study
10 / 10
Completed / Started
Serious Adverse Events
0 / 10
Affected / At Risk
Other Adverse Events
10 / 10
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT00899574. The sponsor of the trial is New York University School of Medicine and it is looking for 10 volunteers for the current phase.
Official trial title: Phase II Evaluation of Imiquimod, a Topical Toll-like Receptor 7 (TLR7) Agonist in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
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