Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and Radiotherapy for Breast Cancer With Skin Metastases
NCT01421017 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2021-11-18
Summary
This study is to find an optimal dose of Imiquimod (IMQ) in the first part (Phase I) and test the effectiveness of the combination treatment of IMQ, cyclophosphamide (CTX), and radiotherapy (RT) in patients with skin metastases from breast cancer in the second part (Phase II). Currently this trial is in its Phase II part.
Conditions
- Breast Cancer
- Metastatic Breast Cancer
- Recurrent Breast Cancer
Interventions
- RADIATION
-
Radiation
- DRUG
-
Imiquimod
- DRUG
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Sylvia Adams, MD · NYU Langone Health
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-19
- Primary Completion
- 2016-07-01
- Completion
- 2016-08-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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