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(Last updated: November 13, 2019)

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1

NEAREST SITE: 1956 miles
Vanderbilt-Ingram Cancer Center
Nashville,TN

VISITS: 2 visits per month, ongoing

PHASE: I-II

NCT ID: NCT03566485

Tecentriq & Cotellic or Idasanutlin for ER+, HER2- Advanced Breast Cancer

BRE 17107: A Phase Ib/II Trial of Atezolizumab (an Anti-PD-L1 Monoclonal Antibody) With Cobimetinib (a MEK1/2 Inhibitor) or Idasanutlin (an MDM2 Antagonist) in Metastatic ER+ Breast Cancer Scientific Title

Purpose
To study the safety and effects (good and bad) of giving an immunotherapy along with a targeted therapy.
Who is this for?
Women with ER positive advanced (some stage III) or metastatic (stage IV) breast cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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">Atezolizumab (Tecentriq®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), by mouth, daily (3 weeks on, 1 week off)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Idasanuttlin, by mouth, 5 days per month</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy used in this study is the PD-L1 inhibitor atezolizumab (Tecentriq®). </li> <li class="seamTextUnorderedListItem">Tecentriq® works by stimulating the body's immune system to go after cancer cells.</li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of cancers but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">The two targeted therapies being used in this study are cobimetinib (Cotellic®), an MEK-targeted therapy approved to treat melanoma, and idasanutlin, a targeted therapy being studied in clinical trials.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03566485' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/patients/medicines/tecentriq' target='_blank'>Genentech: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/Drugs/InformationOnDrugs/ucm478351.htm' target='_blank'>FDA.gov: Cobimetinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/idasanutlin' target='_blank'>NIH: Idasanutlin</a> </li></ul>
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