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(Last updated: May 28, 2020)

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1

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03523572

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 test the safety and effects (good and bad) of an experimental drug called DS-8201 when it is given along with an immunotherapy to treat advanced breast cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low expression breast cancer that 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">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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