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1

NEAREST SITE: 342 miles
California Research Institute
Los Angeles,CA

VISITS: Weekly visits for 4 months

PHASE: I

NCT ID: NCT02626507

Gedatolisib, Ibrance and Faslodex Before Surgery in Women With ER+ HER2- Breast Cancer

Phase I Dose-Escalation Study of Combination of Gedatolisib (a Dual Inhibitor of PI3-K and mTOR) With Palbociclib and Faslodex in the Neoadjuvant Setting in Previously Untreated Patients With ER+/HER2- Breast Cancer Scientific Title

Purpose
To test the safety and effects (good and bad) and best dose of the targeted therapy gedatolisib when used along with fulvestrant (Faslodex®) and palbociclib (Ibrance®).
Who is this for?
Women with ER-positive HER2-negative stage I, II, III or IV (metastatic) breast cancer who has not yet had any breast cancer treatments and is scheduled to have a lumpectomy or a mastectomy.    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">Gedatolisib, by IV, once a week for 4 months</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, twice a month in the first month, then monthly for the remaining 3 months</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily for 3 weeks each month</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by mouth, once a month, if needed</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The purpose of this study is to test the safety and effects (good or bad) and best dose of the targeted therapy gedatolisib when used along with fulvestrant (Faslodex®) and palbociclib (Ibrance®). </li> <li class="seamTextUnorderedListItem">The combination is given before surgery. This is called neoadjuvant treatment. </li> <li class="seamTextUnorderedListItem">Giving therapy before surgery allows researchers to study the effect the therapy has on the breast tumor. </li> <li class="seamTextUnorderedListItem">Gedatolisib kills cancer cells by blocking the PI3K/mTOR pathway. </li> <li class="seamTextUnorderedListItem">Faslodex® is a hormone therapy approved to treat advanced breast cancer in postmenopausal women. </li> <li class="seamTextUnorderedListItem">Ibrance® is a type of targeted therapy called a CDK 4/6 inhibitor. It is approved to treat metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">If you are premenopausal, you will also be given the drug goserelin (Zoladex®), which will put you in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02626507' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancer-news.com/2017/11/15/advanced-breast-cancer-therapy-combo-faslodex-fulvestrant-ibrance-palbociclib-approved-eu/' target='_blank'>Breast Cancer News: European Commission Approves Faslodex-Ibrance Combo for Advanced Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/palbociclib' target='_blank'>NCI Drug dictionary: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/fulvestrant' target='_blank'>NCI Drug dictionary: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/goserelinacetate' target='_blank'>NCI Drug dictionary: Goserelin (Zoladex®)</a> </li></ul>
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