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(Last updated: November 13, 2019)

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03523572

DS-8201a Plus Immunotherapy for HER2 Positive or HER2 Low Expression Advanced 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?
Women and men with HER2 positive or low HER2 expression advanced (some stage III) or metastatic (stage IV) 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'>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></ul>
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