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(Last updated: November 29, 2020)

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NEAREST SITE: 416 miles
Comprehensive Cancer Centers of Nevada CCC of Nevada (1)
Las Vegas,NV

VISITS: 1 visit a week, ongoing

PHASE: III

NCT ID: NCT04251533

Chemotherapy Alone or with Alpelisib for Advanced Triple Negative Breast Cancer with a PIK3CA Mutation or PTEN Loss

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (EPIK-B3) Scientific Title

Purpose
To compare the safety and anti-cancer activity of giving the chemotherapy nab-paclitaxel (Abraxane®) alone or in combination with the targeted therapy Alpelisib (Piqray®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose tumors test positive for a PIK3CA mutation or PTEN loss and who have not received more than one chemotherapy for metastatic disease.    Full eligibility criteria
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  • 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">Alpelisib (Piqray®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy approved to treat advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, which allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) blocks the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA and PTEN loss</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04251533' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/piqray' target='_blank'>Breastcancer.org: Alpelisib</a> </li></ul>
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