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1

ECI830 CDK2 Inhibitor with CDK4/6 Inhibitor and Hormone Therapy for Advanced HR+, HER2- Breast Cancer

An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of ECI830, an experimental; CDK2 inhibitor, with ribociclib (Kisqali®) CDK4/6 inhibitor and fulvestrant (Faslodex®) hormone therapy.

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 have received an aromatase inhibitor or tamoxifen (Nolvadex®) with a CDK4/6 inhibitor. You must not have received more than 2 lines of hormone therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ECI830</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ECI830</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ECI830 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block an enzyme, CDK2, that helps 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> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor-positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®). are letrozole (Femara®), anastrozole (Arimidex®), and exemestane (Aromasin®).</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/NCT06726148' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/clinicaltrials/study/nct06726148' target='_blank'>Novartis: Trial Information Page</a> </li></ul>
1

ECI830 CDK2 Inhibitor with CDK4/6 Inhibitor and Hormone Therapy for Advanced HR+, HER2- Breast Cancer

An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors
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Nearest Location:
336 miles
University of California LA
Los Angeles, CA

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Visits:
At least 1 visit every month

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ClinicalTrials.gov: NCT06726148

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Phase I-II

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