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(Last updated: July 07, 2020)

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1

NEAREST SITE: 74 miles
University of California Davis
Sacramento,CA

VISITS: 1 visit every 3 weeks

PHASE: III

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

Purpose
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"><span class="highlight">Tucatinib</span> (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"><span class="highlight">Tucatinib</span> (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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2

NEAREST SITE: 752 miles
University of Arizona
Tucson,AZ

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03054363

Tucatinib, Ibrance and Femara in Advanced HR+, HER2+ Breast Cancer

Phase IB/II Open-label Single Arm Study to Evaluate Safety and Efficacy of Tucatinib in Combination With Palbociclib and Letrozole in Subjects With Hormone Receptor Positive and HER2-positive Metastatic Breast Cancer Scientific Title

Purpose
To investigate the safety and effects (good and bad) of using two targeted therapies along with a hormone therapy.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) and HER2 positive (HER2+) breast cancer. You must be starting your first or second treatment for advanced cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, ongoing</li></ul>
  • <p class="seamTextPara"> The two targeted therapies being used in this study are <span class="highlight">tucatinib</span> (Tukysa) and palbociclib (Ibrance®). </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa) is a tyrosine kinase inhibitor that targets HER2.</li> <li class="seamTextUnorderedListItem">It is approved to treat some advanced HER2+ breast cancer when used in combination with certain other therapies. </li> <li class="seamTextUnorderedListItem">Ibrance targets the CDK 4/6 protein and is approved by the FDA to treat postmenopausal women with ER+, HER2+ metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">The hormone therapy used in this study is letrozole (Femara®). </li> <li class="seamTextUnorderedListItem">Premenopausal women who enroll in this study will also receive a drug to stop ovarian function.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03054363' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/targeted_therapies/ibrance' target='_blank'>Breastcancer.org: Ibrance</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com/?src_code=IBRW10028851' target='_blank'>Pfizer Oncology Information Page: Ibrance</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tukysahcp.com' target='_blank'>Seattle Genetics Information Page: Tukysa</a> </li></ul>
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3

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. This is when the cancer spreads to the membranes lining the brain and spinal cord.    Full eligibility criteria
Contact research site
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Contact Research Sites

  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (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"><span class="highlight">Tucatinib</span> (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></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></ul>
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