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(Last updated: October 24, 2020)

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NEAREST SITE: 339 miles
UCLA - Medical Center
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03523572

Trastuzumab Deruxtican (DS-8201a) Plus Immunotherapy for Advanced HER2 Positive or HER2 Low Expression Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer Scientific Title

Purpose
To study the safety and effects (good and bad) of the HER2 targeted therapy trastuzumab deruxtican (DS-8201a) when it is given in combination with an immunotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low expression breast cancer whose cancer did not respond to standard therapies    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (DS-8201a), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-8201a (Trastuzumab deruxtecan) is a new type of HER2-targeted therapy. </li> <li class="seamTextUnorderedListItem">It is an antibody-drug conjugate (ADC), which means it uses an antibody to deliver a chemotherapy drug directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or IHC 2+/ISH-</li> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is the PD-1 inhibitor nivolumab (Opdivo®). By blocking PD-1, it allows your immune system to see and go after cancer cells. </li> <li class="seamTextUnorderedListItem">Opdivo is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03523572' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-grants-ds8201-breakthrough-designation-for-her2-breast-cancer' target='_blank'>OncLive: FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/news/updated-analysis-ongoing-phase-trial-ds-8201-confirms-significant-benefit-her2-breast-cancer-patients-pretreated-ado-trastuzumab-emtansine/' target='_blank'>ADC Review: Trial Update of DS-8201</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/april-10-2018/potent-anti-her2-agents-on-the-horizon/' target='_blank'>ASCO: Potent Anti-HER2 Agents</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/' target='_blank'>ADC Review: What Are Antibody-Drug Conjugates?</a> </li></ul>
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