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(Last updated: October 21, 2020)

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1

NEAREST SITE: 1562 miles
Highlands Oncology Group
Fayetteville,AR

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT04208178

Alpelisib for Advanced HER2+ Breast Cancer with a PIK3CA Mutation

EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation Scientific Title

Purpose
To study the best dose and anti-cancer activity of combining the PI3K inhibitor alpelisib (Piqray®) with the anti-HER2 therapies trastuzumab (Herceptin®) and pertuzumab (Perjeta®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer that tests positive for a PIK3CA mutation. You must have already received chemotherapy.    Full eligibility criteria
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  • <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">Trastuzumab (Herceptin®), by IV, once every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, once every 3 weeks, 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">Trastuzumab (Herceptin®), by IV, once every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, once every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <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">Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are HER2-targeted therapies used to treat early-stage and metastatic HER2 positive (HER2+) breast cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04208178' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/alpelisib-changing-clinical-landscape-breast-cancer-treatment' target='_blank'>Cancer Network: Alpelisib Is Changing the Clinical Landscape in Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/tucatinib-trastuzumab-deruxtecan-her2-positive-metastatic-breast-cancer' target='_blank'>NCI Cancer Currents Blog: For Metastatic HER2-Positive Breast Cancer, New Treatments Emerge</a> </li></ul>
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