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1

Eniluracil Targeted Therapy with Chemotherapy for Advanced HER2- Breast Cancer

A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of eniluracil (PCS6422), an experimental DPD inhibitor, with capecitabine (Xeloda®) compared to capecitabine (Xeloda®) alone.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer who have received chemotherapy 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">Eniluracil (PCS6422), 1 time</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eniluracil (PCS6422) is an experimental targeted therapy called a DPD inhibitor that, when combined with capecitabine (Xeloda®), may make the immune response more active against cancer.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug.</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/NCT06568692' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/fixed-dose-eniluracil-under-investigation-in-advanced-refractory-gastrointestinal-cancers' target='_blank'>OncLive: Eniluracil for Advanced Gastrointestinal Cancers</a> </li></ul>
1

Eniluracil Targeted Therapy with Chemotherapy for Advanced HER2- Breast Cancer

A Phase 2, Open-Label Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
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Nearest Location:
340 miles
Valkyrie Clinical Trials
Los Angeles, CA

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Visits:
1 visit every 3 months

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ClinicalTrials.gov: NCT06568692

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Phase II

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