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(Last updated: September 27, 2020)

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1

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: 1 visit every 2 or 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT04108858

Copanlisib for Stage IV HER2 Positive Breast Cancer with a PIK3CA or PTEN Mutation

Phase Ib/II Trial of Copanlisib in Combination With Trastuzumab and Pertuzumab After Induction Treatment of HER2 Positive (HER2+) Metastatic Breast Cancer (MBC) With PIK3CA Mutation or PTEN Mutation Scientific Title

Purpose
To study the best dose, effects (good and bad), and anti-cancer activity of adding copanlisib (Aliqopa®) to the combination of trastuzumab (Herceptin®) and pertuzumab (Perjeta®).
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that tests positive for a PIK3CA or PTEN mutation and who have already received chemotherapy for metastatic disease.    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: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Copanlisib (Aliqopa®), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Copanlisib (Aliqopa®) is a type of targeted therapy called a PI3K inhibitor. It is approved for use in lymphoma, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies routinely used to for HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA (PI3K) and PTEN</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04108858' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aliqopa-us.com/?utm_source=google&utm_medium=cpc&utm_campaign=Aliqopa_Branded_Patient_%3BS%3BPH%3BBR%3BONC%3BDTC%3BBR&utm_content=General&utm_term=copanlisib&matchtype=e&device=c&adposition=&loc=9008590&gclid=Cj0KCQjwjer4BRCZARIsABK4QeVEb_yjzH' target='_blank'>Bayer Drug Information Page: Aliqopa® (Copanlisib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies' target='_blank'>Breastcancer.org: Targeted Therapies</a> </li></ul>
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