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Utidelone Chemotherapy for Metastatic HER2- or HER2 Low Breast Cancer with Brain Metastases

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of utidelone (UTD1), an experimental chemotherapy, with capecitabine (Xeloda®) chemotherapy.

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) or HER2 low breast cancer that has spread to the brain (brain metastases) who have received no more than 3 lines of chemotherapy for metastatic disease. You must not have leptomeningeal metastasis (leptomeningeal disease). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utidelone (UTD1), by injection, daily for 5 days, every 3 weeks</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utidelone (UTD1) is an experimental chemotherapy drug that may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is an FDA approved chemotherapy drug.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</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/NCT06764940' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/utd1-receives-fda-orphan-drug-designation-in-breast-cancer-brain-metastasis' target='_blank'>OncLive: UTD1 for Breast Cancer Brain Metastasis</a> </li></ul>
1

Utidelone Chemotherapy for Metastatic HER2- or HER2 Low Breast Cancer with Brain Metastases

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases
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Nearest Location:
304 miles
FOMAT Medical Research (Network)
Oxnard, CA

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Visits:
At least 5 visits every 3 weeks

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ClinicalTrials.gov: NCT06764940

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Phase II

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