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1

NEAREST SITE: 2376 miles
University of Virginia
Charlottesville,VA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04116320

FUSA Alone or With Immunotherapy in Advanced Breast Cancer

Pilot Evaluation of Focused Ultrasound Ablation and Focused Ultrasound Ablation Plus PD-1 Antibody Blockade in Advanced Solid Tumors Scientific Title

Purpose
To compare the safety and effects (good or bad) of Focused Ultrasound Ablation (FUSA) when it is used alone, with a PD-1 inhibitor, with imiquimod (Aldara®), or with both a PD-1 inhibitor and imiquimod (Aldara®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 4 groups depending on your diagnosis: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Focused Ultrasound Ablation (FUSA), once</li> <li class="seamTextUnorderedListItem">PD-1 inhibitor therapy, by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Focused Ultrasound Ablation (FUSA), once</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Focused Ultrasound Ablation (FUSA), once</li> <li class="seamTextUnorderedListItem">PD-1 inhibitor therapy, by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Imiquimod (Aldara®), cream applied to skin</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Focused Ultrasound Ablation (FUSA), once</li> <li class="seamTextUnorderedListItem">Imiquimod (Aldara®), cream applied to skin</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FUSA (Focused Ultrasound Ablation) uses ultrasound waves to kill cancer cells. It may also trigger your immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy called a checkpoint inhibitor. They stimulate the body's immune system to fight cancer cells. </li> <li class="seamTextUnorderedListItem">Imiquimod (Aldara®) is a cream-based immunotherapy. It is used to treat skin cancer and other types of skin disorders. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancers.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04116320' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://fusfoundation.org/diseases-and-conditions/oncological/breast-cancer' target='_blank'>Focused Ultrasound Foundation: Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.researchgate.net/figure/Ultrasound-guided-focused-ultrasound-ablation-device-Echopulse-Theraclion-VTU_fig1_268788751' target='_blank'>ResearchGate: Echopulse</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/imiquimod' target='_blank'>NCI Drug Dictionary: Imiquimod</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncologypro.esmo.org/Oncology-News/OncologyNews-archives-2017/Topical-Imiquimod-Regimen-Shows-Promise-For-Chest-Wall-Cutaneous-Breast-Cancer-Metastases' target='_blank'>ESMO: Topical Imiquimod Regimen Shows Promise For Chest Wall, Cutaneous Breast Cancer Metastases</a> </li></ul>
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