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(Last updated: May 21, 2020)

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NEAREST SITE: 74 miles
University of California Davis

VISITS: 1 visit every 3 weeks


NCT ID: NCT03975647

T-DM1 and Tucatinib for Advanced HER2+ Breast Cancer

Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer Scientific Title

To compare the effects (good and bad) of tucatinib (Tukysa) and T-DM1 to T-DM1 and a placebo.
Who is this for?
Women with locally advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have previously been treated with a taxane and trastuzumab (Herceptin®).    Full eligibility criteria
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  • What's involved?
  • 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</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa), by mouth, twice daily </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa) is a HER2-targeted therapy approved for use with certain other therapies. Its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody—the HER2-targeted therapy trastuzumab (Herceptin®)—to deliver the chemotherapy drug DM1 directly to the cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03975647' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tukysahcp.com' target='_blank'>Seattle Genetics Information Page: Tukysa (Tucatinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Kadcyla® (T-DM1)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2018/vol-19-no-24/tucatinib-shows-promise-in-patients-with-breast-cancer-and-brain-metastases' target='_blank'>OncLive: Tucatinib Shows Promise in Patients With Breast Cancer and Brain Metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/news/tucatinib-shows-promise-phase-i-study-her2-positive-breast-cancer' target='_blank'>CancerNetwork:Tucatinib Shows Promise in Phase I Study of HER2-Positive Breast Cancer</a> </li></ul>
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