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(Last updated: October 24, 2020)

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1

NEAREST SITE: 1643 miles
University of Texas MD Anderson Cancer Center
Houston,TX

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03501979

Tucatinib, Trastuzumab, and Capecitabine for HER2+ Breast Cancer with Leptomeningeal Metastases

A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer Scientific Title

Purpose
To look at the safety and effects (good and bad) of using tucatinib (Tukysa) along with trastuzumab (Herceptin®) and capecitabine (Xeloda®).
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with leptomeningeal metastases (defined below).    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, twice daily, 2 weeks on and 1 week off</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa) is a HER2-targeted therapy approved to treat some advanced HER2+ breast cancer in combination with certain other therapies. </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a commonly used HER2-targeted therapy. </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a type of chemotherapy.</li> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03501979' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/capecitabine' target='_blank'>CancerResearchUK: Capecitabine (Xeloda®)</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.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.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: Leptomeningeal Metastases</a> </li></ul>
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