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(Last updated: September 27, 2020)

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NEAREST SITE: 2693 miles
Dana Farber Cancer Institute
Boston,MA

VISITS: 1 visit per week

PHASE: II

NCT ID: NCT04468061

Sacituzumab Govitecan with or without Pembrolizumab for Advanced Triple Negative or ER-Low, HER2- Breast Cancer

Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose
To study the safety and anti-cancer activity of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy) alone and in combination with the immunotherapy pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-. HER2-) or ER-Low (1%-10% ER), HER2 negative breast cancer that is PD-L1 negative, who have not yet started treatment for metastatic disease.    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">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic triple negative breast cancer who have already received at least two other therapies for metastatic disease. But its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low. This trial is enrolling people with triple negative as well as ER-Low, HER2 negative breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04468061' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-sacituzumab-govitecan-triple-negative-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/dosing' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/pembrolizumab' target='_blank'>Cancer Research UK: Pembrolizumab (Keytruda)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/lab-tests/pdl1-immunotherapy-tests/' target='_blank'>NIH MedlinePlus: PDL1 (Immunotherapy) Tests</a> </li></ul>
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