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(Last updated: October 24, 2020)

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NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX

VISITS: 2 visits every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03992131

Rucaparib & Sacituzumab Govitecan for Metastatic Triple Negative Breast Cancer

SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor Scientific Title

Purpose
To study the safety and effects (good and bad) of the combining the targeted therapies rucaparib (Rubraca®) and sacituzumab govitecan (Trodelvy).
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has been treated with at least one standard therapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rucaparib (Rubraca®), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV, 2 times every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rucaparib (Rubraca®) is a PARP inhibitor approved to treat recurrent ovarian, fallopian tube, and primary peritoneal cancer. </li> <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/NCT03992131' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/rucaparib-phosphate' target='_blank'>NCI Drug Dictionary: Rucaparib (Rubraca®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rubraca.com/' target='_blank'>Clovis Oncology Drug Information Page: Rubraca® (Rucaparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sacituzumab-govitecan' target='_blank'>NCI Drug Dictionary: Sacituzumab Govitecan (Trodelvy)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan-Hziy)</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></ul>
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