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(Last updated: October 14, 2021)

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1

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04296942

Vaccine, Entinostat, Adotrastuzumab Emtansine and Bintrafusp Alfa for Metastatic HER2 Positive and Hormone Negative Breast Cancer

A Phase 1b Trial of Sequential Combinations of BN-Brachyury, Entinostat, Ado-trastuzuamb Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) Scientific Title

Purpose
To study the safety, anti-cancer activity and other effects (good and bad) of giving a combination of immunotherapies alone, with an antibody-drug conjugate, or with an antibody-drug conjugate and a targeted therapy.
Who is this for?
People with metastatic (stage IV), hormone negative (ER- and PR-) breast cancer who have already received at least one therapy for metastatic disease.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MVA-BN-Brachyury, by injection, every 3 weeks for 6 months, then every 3 months, ongoing </li> <li class="seamTextUnorderedListItem">FPV-BN-Brachyury, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">M7824 (bintrafusp alfa), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MVA-BN-Brachyury, by injection, every 3 weeks for 6 months, then every 3 months, ongoing </li> <li class="seamTextUnorderedListItem">FPV-BN-Brachyury, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">M7824 (bintrafusp alfa), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Ado-trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MVA-BN-Brachyury, by injection, every 3 weeks for 6 months, then every 3 months, ongoing </li> <li class="seamTextUnorderedListItem">FPV-BN-Brachyury, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">M7824 (bintrafusp alfa), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Ado-trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Entinostat, by mouth, once a week, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Brachyury injections are vaccines that researchers believe will help your immune system go after cancer cells. </li> <li class="seamTextUnorderedListItem">Bintrafusp alfa (M7824) is an investigational immunotherapy. It is designed to get the immune system to go after cancer cells by blocking the proteins PD-L1 and TGF-beta.</li> <li class="seamTextUnorderedListItem">Ado-trastuzumab emtansine (Kadcyla®) is an antibody-drug conjugate (ADC). It uses trastuzumab to deliver the chemotherapy DM1 directly to the cancer cells. It is approved to treat HER2 positive metastatic breast cancer, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Entinostat is an investigational targeted therapy called an HDAC inhibitor.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04296942' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bavarian-nordic.com/what-we-do/cancer-immunotherapy/chordoma.aspx' target='_blank'>Bavarian Nordic Drug Information Page: BN-BRACHYURY</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/io-m7824/?cn-reloaded=1' target='_blank'>Immunotherapy-Oncology News: M7824(Bintrafusp Alfa)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/ado-trastuzumab-emtansine' target='_blank'>NCI Drug Dictionary: Ado-Trastuzumab Emtansine</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.syndax.com/pipeline/entinostat/' target='_blank'>Syndax Drug Information Page: Entinostat</a> </li></ul>
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