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(Last updated: May 21, 2020)

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NEAREST SITE: 533 miles
Oregon Health and Sciences University

VISITS: 1 visit every 3 weeks, ongoing


NCT ID: NCT03530696

T-DM1 and Palbociclib for Advanced HER2 Positive Breast Cancer

A Randomized Phase II Study to Evaluate Efficacy of T-DM1 With or Without Palbociclib in the Treatment of Patients With Metastatic HER2 Positive Breast Cancer Scientific Title

To compare the side effects and effectiveness of the combination of T-DM1 (Kadcyla®) and palbociclib (Ibrance®) to T-DM1 (Kadcyla®) alone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2-positive breast cancer.    Full eligibility criteria
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  • 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">Palbociclib (Ibrance®), by mouth, daily, 2 weeks on, 1 week off </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®), by IV, once every 3 weeks </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Kadcyla® is a HER2-targeted therapy that combines the chemotherapy drug DM1 with the HER2 targeted therapy trastuzumab (Herceptin). </li> <li class="seamTextUnorderedListItem">It is approved for patients with previously treated HER2-positive metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">Ibrance® is a CDK4/6 inhibitor approved to treat metastatic breast cancer when given along with hormone therapy--either letrozole (Femara®) or fulvestrant (Faslodex®).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03530696' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cslide.ctimeetingtech.com/library/esmo/browse/search/258K#2F3503b' target='_blank'>ESMO: Palbociclib in combination with TDM1 for metastatic HER2+ breast cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/RecommendedTreatmentsforMetastaticBreastCancer.html' target='_blank'>Susan G. Komen: Trastuzumab emtansine (T-DM1, Kadcyla)</a> </li></ul>
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