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(Last updated: February 26, 2021)

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NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04294628

Trastuzumab Deruxtican for Advanced Breast Cancer that is HER2 Positive, HER2 Expressing or Tests Positive for a HER2 Mutation

Pilot Study of DS-8201a Pharmacodynamics in Patients With HER2-Expressing Advanced Solid Tumors Scientific Title

Purpose
To study the safety, anti-cancer activity and other effects (good and bad) of giving the antibody-drug conjugate fam-trastuzumab-deruxtican-nxki (Enhertu®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer that is HER2 positive (HER2+), HER2 expressing (defined below) or positive for a HER2 mutation; and who have no standard of care treatment options available.    Full eligibility criteria
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  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fam-trastuzumab deruxtican-nxki (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 expressing (HER2 low expressing) tumors are defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">Some tumors test positive for a HER2 gene mutation. </li> <li class="seamTextUnorderedListItem">Fam-trastuzumab deruxtican-nxki (Enhertu®) is an antibody-drug conjugate (ADC)--it uses a HER2 antibody to deliver a chemotherapy directly to cancer cells. It is approved for use in some people with metastatic HER2 positive breast cancer, but its use for HER2 expressing or HER2 mutated breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER2 (ERBB2)</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04294628' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-low-expressing-a-new-subcategory-of-her2-negative-breast-cancer/' target='_blank'>Metastatic Trial Talk: HER2-Low Expressing Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/enhertu' target='_blank'>Breastcancer.org: Fam-Trastuzumab-Deruxtecan-nxki</a> </li></ul>
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