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1

Afuresertib Targeted Therapy with Fulvestrant for Advanced HR+, HER2- Breast Cancer with PIK3CA, AKT1, or PTEN Mutations

A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care Therapies (LAE205INT3101)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of afuresertib (LAE002), an experimental AKT inhibitor, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with PIK3CA, AKT1, or PTEN mutations that has progressed after 1 -2 lines of therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Afuresertib (LAE002), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Fulvestrant and Placebo</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for afuresertib (LAE002), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Afuresertib (LAE002) is an experimental targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04851613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.saintjohnscancer.org/clinical-trials/clinical-trial/study-evaluating-efficacy-safety-of-afuresertib-plus-fulvestrant-in-patients-w-locally-advanced-or-metastatic-hr-her2-breast-cancer/' target='_blank'>Saint John’s Cancer Institute: Clinical Trial Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/laekna-therapeutics-receives-ind-approvals-in-china-and-us-for-phase-ibiii-global-multi-center-clinical-study-of-afuresertib-in-combination-with-fulvestrant-for-patients-with-hrher2--breast-cancer-301364146.html' target='_blank'>Laekna Therapeutics Press Release: Afuresertib With Fulvestrant for Advanced HR+, HER2- Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
1

Afuresertib Targeted Therapy with Fulvestrant for Advanced HR+, HER2- Breast Cancer with PIK3CA, AKT1, or PTEN Mutations

A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care Therapies (LAE205INT3101)
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Nearest Location:
339 miles
Providence St. Johns Health Center
Santa Monica, CA

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Visits:
1-2 visits every month

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ClinicalTrials.gov: NCT04851613

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Phase III

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