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1

Zunsemetinib Targeted Therapy with Chemotherapy for Metastatic HR+, HER2- Breast Cancer with Bone Metastasis

A Phase Ib/II Trial of Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

Purpose: To study the safety, best dose, and effects (good and bad) of zunsemetinib, an experimental targeted therapy, with chemotherapy compared to standard of care.

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has spread to the bone (bone metastasis). You must have received 1 line of hormone therapy with a CDK4/6 inhibitor and no more than 1 line of chemotherapy for metastatic 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: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bisphosphonate (zoledronic acid) or denosumab, every 1-3 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zunsemetinib, by mouth, daily</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">Zunsemetinib is an experimental targeted therapy called an MK2 inhibitor. Blocking MK2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Zunsemetinib targets a molecule that may play a role in inflammation and bone loss.</li> <li class="seamTextUnorderedListItem">Bisphosphonate (zoledronic acid) and denosumab are standard of care drugs that help strengthen bones but have little effect on pain relief and anti-cancer activity.</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/NCT06374459' target='_blank'>ClinicalTrials.gov</a> </li></ul>
1

Zunsemetinib Targeted Therapy with Chemotherapy for Metastatic HR+, HER2- Breast Cancer with Bone Metastasis

A Phase Ib/II Trial of Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
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Nearest Location:
1739 miles
Washington University School of Medicine
Saint Louis, MO

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Visits:
Weekly for 3 weeks, then 1 visit every 3 weeks

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ClinicalTrials.gov: NCT06374459

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Phase I-II

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