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1

<span class="highlight">Gedatolisib</span> Targeted Therapy with CDK4/6 Inhibitor and Hormone Therapy for Advanced HR+, HER2- Breast Cancer

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without <span class="highlight">Gedatolisib</span> as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of <span class="highlight">gedatolisib,</span> an experimental targeted therapy, with standard of care CDK4/6 inhibitor and hormone therapy compared to standard of care alone.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who were diagnosed with advanced disease during or within 1 year of completing hormone therapy. You must have not yet received treatment for advanced disease. View full eligibility criteria

What's involved?

<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"><span class="highlight">Gedatolisib,</span> by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy called a pan-PI3K/mTOR inhibitor. Blocking PI3K/mTOR may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and ribociclib (Kisqali®) are types of targeted therapies called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (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/NCT06757634' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/our-approach/viktoria-2-2/' target='_blank'>Celcuity: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/gedatolisib/' target='_blank'>Celcuity: Gedatolisib Drug Information Page</a> </li></ul>
1

<span class="highlight">Gedatolisib</span> Targeted Therapy with CDK4/6 Inhibitor and Hormone Therapy for Advanced HR+, HER2- Breast Cancer

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without <span class="highlight">Gedatolisib</span> as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer
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Nearest Location from 94107:
339 miles
UCLA Hematology Oncology Santa Monica
Los Angeles, CA

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Visits:
1 visit every 1-2 weeks

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ClinicalTrials.gov: NCT06757634

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Phase III

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