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1

NEAREST SITE: 1578 miles
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park,MN

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04351230

Trastuzumab Emtansine/T-DM1 With or Without Abemaciclib for Advanced HER2 Positive Breast Cancer

Phase II Trial of Abemaciclib and T-DM1 in Women and Men With HER2-positive Advanced or Metastatic Breast Cancer Who Progressed on Treatment With a Taxane, Trastuzumab and Pertuzumab Scientific Title

Purpose
To study the anti-cancer activity of giving the antibody-drug conjugate trastuzumab emtansine/T-DM1 (Kadcyla®) alone or in combination with the CDK 4/6 inhibitor abemaciclib (Verzenio®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer.    Full eligibility criteria
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  • <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">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an ADC. It combines the chemotherapy DM1 with the HER2 targeted therapy trastuzumab. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer. Its use in this trial is considered experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04351230' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.kadcyla.com/patient/metastatic-breast-cancer.html' target='_blank'>Genentech Drug Information Page: Kadcyla® (Trastuzumab Emtansine)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab emtansine/T-DM1 (Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/november-10-2019/abemaciclib-benefits-patients-with-her2-positive-breast-cancer-in-monarcher-trial/' target='_blank'>ASCO Post: Abemaciclib Benefits Patients With HER2-Positive Breast Cancer</a> </li></ul>
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