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(Last updated: November 13, 2019)

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1

NEAREST SITE: 2619 miles
Dartmouth Hitchcock Medical Center
Lebanon,NH

VISITS: 2 visits in the first 3 weeks; number of visits unavailable over next 4 months

PHASE: I

NCT ID: NCT02619669

TAK-228 and Letrozole in Postmenopausal Women With High-Risk ER+ and HER2-Low Breast Cancer

Phase 1b Neoadjuvant Run-In Study With TAK-228 Followed by Letrozole/TAK-228 in Women With High-Risk ER+/HER2- Breast Cancer Scientific Title

Purpose
To study the safety and effects (good and bad) of the combination of TAK-228 and letrozole (Femara®) when given before surgery.
Who is this for?
Postmenopausal women with stage I, stage II, stage III or metastatic (stage IV) breast cancer that is estrogen receptor (ER) positive and low HER2 (defined as IHC 0-1+) and has a high risk for recurrence.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following treatment before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAK-228, by mouth, for 10 days</li> <li class="seamTextUnorderedListItem">TAK-228 and letrozole (Femara®), by mouth, for approximately 4 months</li> <li class="seamTextUnorderedListItem">2 biopsies within 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is investigating the safety and effects (good or bad) of the combination of TAK-228 and letrozole (Femara®) when given before surgery. </li> <li class="seamTextUnorderedListItem">Your tumor is HER2 low if the results of your immunohistochemical (IHC) test for HER2 were 0 or 1.</li> <li class="seamTextUnorderedListItem">This is called neoadjuvant treatment. </li> <li class="seamTextUnorderedListItem">TAK-228 is a new type of targeted therapy called a TORC inhibitor. </li> <li class="seamTextUnorderedListItem">Femara® is a type of hormone therapy called an aromatase inhibitor. It is approved to treat postmenopausal women with breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02619669' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sapanisertib' target='_blank'>NCI Drug Dictionary: TAK-228</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.practiceupdate.com/content/tak-228-plus-hormonal-therapy-for-metastatic-er-positiveher2-negative-breast-cancer/77349' target='_blank'>Practice Update: TAK-228 Plus Hormonal Therapy for Metastatic, ER+/HER2- Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedaily.com/releases/2017/11/171101130336.htm' target='_blank'>Science Daily: In the lab and in the clinic, alisertib with TAK-228 excels against solid tumors</a> </li></ul>
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