Phase 2
Completed N=10
Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
Source: ClinicalTrials.gov NCT00899574 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Objective Response (Complete Clinical Response+ Partial Response) — 20 percentage of patients
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response (Complete Clinical Response+ Partial Response) |
20 | — |
| SECONDARY Clinical Benefits |
4; 5; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 = 1,500/microliter
- hemoglobin > or = 9.5 grams/deciliter
- platelets >or = 75,000/microliter
- total bilirubin 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.
Data sourced from ClinicalTrials.gov (NCT00899574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.