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NEAREST SITE: 86 miles
Pacific Cancer Care
Monterey,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03523585

Trastuzumab Deruxtican (DS-8201a) Versus Standard of Care for Advanced HER2 Positive Breast Cancer

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T DM1 [DESTINY-Breast02] Scientific Title

Purpose
To compare the effects (good and bad) of the HER2 targeted therapy trastuzumab deruxtican (DS-8201a) to the standard of care in patients with advanced breast cancer who have already received the HER2 targeted therapy Kadcyla.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer who have already received T-DM1 (Kadcyla®).    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 3 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 (please contact research site for treatment schedule)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, 2 times per day</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, 2 times per day</li> <li class="seamTextUnorderedListItem">Lapatinib (Tykerb®), by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-8201a (Trastuzumab deruxtecan) is an experimental HER2-targeted therapy, it is also an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">ADC uses an antibody—the HER2-targeted therapy trastuzumab (Herceptin®)—to deliver the chemotherapy drug directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is approved to treat HER2-positive metastatic breast cancer that has previously been treated with Herceptin and a taxane chemotherapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03523585' 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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