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(Last updated: August 03, 2020)

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NEAREST SITE: 1739 miles
Washington University School Of Medicine
Saint Louis,MO

VISITS: Number of visits unavailable


NCT ID: NCT04132817

Chemotherapy Plus One or Two Immunotherapies for Women With Advanced ER Positive, HER2 Negative Breast Cancer

A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer Scientific Title

To study the safety, effects (good and bad), and anti-cancer activity of the chemotherapy nab-paclitaxel (Abraxane®) in combination with immunotherapy: either nivolumab (Opdivo®) or nivolumab and ipilimumab (Yervoy®).
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received at least one but no more than three lines of treatment for advanced or metastatic disease.    Full eligibility criteria
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  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Ipilimumab (Yervoy®), by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">Ipilimumab (Yerovy®) is a type of immunotherapy called a CTLA-4 inhibitor.</li> <li class="seamTextUnorderedListItem">Neither immunotherapy drug is approved to treat breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04132817' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT04132817.html?id=NCT04132817&location=New%20York,%20NY,%20USA&geo_lati=40.7127753&geo_long=-74.0059728' target='_blank'>Bristol-Meyers Squibb Study Information</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.opdivo.com' target='_blank'>Bristol-Meyers Squibb Drug Information Page: Opdivo® (Nivolumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.yervoy.com/metastatic/what-is-yervoy' target='_blank'>Bristol-Meyers Squibb Drug Information Page: Yervoy® (Ipilimumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41598-019-57380-0' target='_blank'>Journal Article: Efficacy and safety of Nab-Paclitaxel</a> </li></ul>
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