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(Last updated: October 24, 2020)

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NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: 2 visits every 3 weeks; or coincides with chemotherapy treatment

PHASE: III

NCT ID: NCT03901339

Sacituzumab Govitecan in Advanced Hormone Positive, HER2 Negative Breast Cancer (TROPICS-02)

Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens Scientific Title

Purpose
To compare the safety and effects (good and bad) of the targeted therapy sacituzumab govitecan (Trodelvy) to standard of care chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has already been treated with 2 to 4 chemotherapies. .    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: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV, 2 times every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine), as determined by your physician</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></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03901339' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/latest-news/fda-approves-trodelvy-sacituzumab-govitecan-hziy-for-triple-negative-breast-cancer.html' target='_blank'>American Cancer Society: FDA Approves Trodelvy (Sacituzumab Govitecan-Hziy) for Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>MetastaticTrialTalk: Getting to the Target, Antibody Drug Conjugates in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan-Hziy)</a> </li></ul>
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