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(Last updated: October 21, 2020)

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NEAREST SITE: 3 miles
University of California at San Francisco (PARENT)
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT03734029

Trastuzumab Deruxtican (DS-8201a) for Advanced HER2 Low Expression Breast Cancer

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [DESTINY-Breast04] Scientific Title

Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of the targeted therapy trastuzumab deruxtican (DS-8201a) to the standard of care.
Who is this for?
People with advanced (stage III that cannot be removed by surgery) or metastatic (stage IV) HER2 low expression breast cancer.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (DS-8201a), by IV, every 3 weeks, ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">your doctor's choice of chemotherapy: capecitabine (Xeloda®), eribulin (Halaven®), gemcitabine (Gemzar®), paclitaxel (Taxol®), or nab-paclitaxel (Abraxane®)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or IHC 2+/ISH-</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (DS-8201a) is an antibody-drug conjugate (ADC). It uses a HER2 antibody to deliver a chemotherapy directly to cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03734029' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/clinical-trials/19-100' target='_blank'>Memorial Sloan Kettering Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Trastuzumab_deruxtecan' target='_blank'>Wikipedia: Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/10.1200/JCO.19.02488' target='_blank'>Journal Article: HER2-Low Breast Cancer: Pathological and Clinical Landscape</a> </li></ul>
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