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1

Axatilimab Immunotherapy with Targeted Therapy for Metastatic HER2 Negative Breast Cancer with BRCA1/2 or PALB2 Mutations

Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

Purpose: To study the safety, best dose, and effects (good and bad) of axatilimab, an experimental immunotherapy, with olaparib (Lynparza®) PARP inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) or HER2 low breast cancer with tumor or inherited BRCA1 or BRCA2 mutations or inherited PALB2 mutations. You must not have received more than 2 lines of chemotherapy, antibody drug conjugates (ADC), and/or immunotherapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Axatilimab, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily</li> <li class="seamTextUnorderedListItem">MRI and/or CT scans, every 2 months</li> <li class="seamTextUnorderedListItem">Electrocardiograms</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Axatilimab is an experimental immunotherapy drug that may help the immune system go after and kill cancer drugs.</li> <li class="seamTextUnorderedListItem">Axatilimab is approved to treat Graft-Versus-Host Disease (GVHD), and its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">An electrocardiogram (ECG) test records electrical signals in your heart.</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/NCT06488378' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/clinical-trials/24-155' target='_blank'>Dana-Farber Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/axatilimab' target='_blank'>National Cancer Institute: Axatilimab</a> </li></ul>
1

Axatilimab Immunotherapy with Targeted Therapy for Metastatic HER2 Negative Breast Cancer with BRCA1/2 or PALB2 Mutations

Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
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Nearest Location:
2693 miles
Dana-Farber Cancer Institute
Boston, MA

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Visits:
1 visit every 2 weeks

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ClinicalTrials.gov: NCT06488378

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Phase I

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