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(Last updated: August 03, 2020)

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1

NEAREST SITE: 1735 miles
Washington University
Saint Louis,MO

VISITS: 1 visit per week

PHASE: I

NCT ID: NCT03767335

MEN1611 & Trastuzumab In Advanced HER2 Positive Breast Cancer With A PIK3CA Mutation

Open-label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined With Trastuzumab With or Without Fulvestrant, in Subjects With PIK3CA Mutated HER2 Positive Locally Recurrent Unresectable (Advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy Scientific Title

Purpose
To study the best dose, safety, side effects, and anti-cancer activity of giving the experimental PI3K inhibitor MEN1611 in combination with the anti-HER2 targeted therapy trastuzumab (Herceptin®), with and without the anti-hormone drug fulvestrant (Faslodex®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), breast cancer whose tumor has a PIK3CA mutation and whose disease progressed after receiving trastuzumab (Herceptin®) and at least one other anti-HER2 therapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEN1611, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) by IV, weekly</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly (only if you are postmenopausal and your cancer is hormone positive)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEN1611 is a type of targeted therapy called a PI3K inhibitor. PI3K is a protein that is involved in cancer cell growth. MEN1611 blocks this protein.</li> <li class="seamTextUnorderedListItem">MEN1611 is an investigational drug, which means it is only available in clinical trials.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy. It is commonly used to treat people with HER2 positive (HER2+) breast cancer. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy that is commonly used to treat postmenopausal women with metastatic, hormone positive (ER+ and/or PR+) 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/NCT03767335' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.menarini.com/Home/Innovation-Research/MEN1611' target='_blank'>The Menarini Group Information Page: MEN1611</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellhealth.com/pik3ca-mutations-in-metastatic-breast-cancer-4689488' target='_blank'>Verywell Health: PIK3CA Mutations in Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/trastuzumab' target='_blank'>NCI A to Z List of Cancer Drugs: Trastuzumab</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/fulvestrant.aspx' target='_blank'>Chemocare: Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.faslodex.com/home.html' target='_blank'>AstraZeneca Information Page: Faslodex (Fulvestrant)</a> </li></ul>
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