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1

NEAREST SITE: 455 miles
Kaiser Permanente-SCPMG; Oncology Research
San Diego,CA

VISITS: 3 visits a month, ongoing

PHASE: III

NCT ID: NCT04177108

Paclitaxel Alone or With Ipatasertib and/or Atezolizumab for People with Advanced TNBC

A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer. Scientific Title

Purpose
To look at at the safety and effects (good and bad) of the experimental targeted therapy ipatasertib (GDC-0068) when it is used along with the chemotherapy drug paclitaxel (Taxol®) and the immunotherapy atezolizumab (Tecentriq®).
Who is this for?
People who are starting treatment for advanced (some stage III) or metastatic (stage IV) triple negative breast cancer.    Full eligibility criteria
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  • What's being studied?
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  • <p class="seamTextPara"> If your tumor is negative for PD-L1, you will be randomly assigned to 1 of 3 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">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> <p class="seamTextPara"> If your tumor is positive for PD-L1, 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">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (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">Placebo, by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib is a type of targeted therapy called an AKT inhibitor. AKT is a protein that helps cancers grow.</li> <li class="seamTextUnorderedListItem">Tecentriq® is a type of immunotherapy called a PD-L1 (programmed death-ligand 1) inhibitor. It is approved for use along with Taxol to treat metastatic triple negative breast cancer that tests positive for PD-L1.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04177108' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2017/05/what-is-a-pd-l1-test/' target='_blank'>Dana-Farber Cancer Institute: What is PD-L1?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/atezolizumab-triple-negative-breast-cancer-fda-approval' target='_blank'>NCI Cancer Currents Blog: Atezolizumab Approved for Some Patients with Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biooncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Information Page: Ipatasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/taxol-better-than-ixempra-or-abraxane' target='_blank'>Breastcancer.org: Study Confirms Taxol Better Than Ixempra or Abraxane for Locally Advanced or Metastatic Disease</a> </li></ul>
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