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1

Single Protein Encapsulated Doxorubicin (SPEDOX-6) Chemotherapy for Advanced Triple Negative Breast Cancer

Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of single protein encapsulated doxorubicin (SPEDOX-6) chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received at least 2 prior lines of therapy but not an anthracycline. 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</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SPEEDOX-6, by IV, every 3 weeks for 4.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SPEEDOX-6, by IV, every 3 weeks for 4.5 months</li> <li class="seamTextUnorderedListItem">Filgrastim (Neupogen®) or pegfilgrastim (Neulasta®), by injection or IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SPEDOX-6 is a form of the chemotherapy medication doxorubicin that may cause less damage to the heart than traditional doxorubicin.</li> <li class="seamTextUnorderedListItem">Anthracyclines are doxorubicin (Doxil®), epirubicin (Ellence®), mitoxantrone (Novantrone®), and idarubicin (Idamycin®).</li> <li class="seamTextUnorderedListItem">Filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) are used to treat low white blood cell counts caused by some cancer medications.</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/NCT07064018' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/resources-support/mbc-heart-problems/' target='_blank'>Metastatic Trial Talk: MBC Treatment-Related Heart Problems</a> </li></ul>
1

Single Protein Encapsulated Doxorubicin (SPEDOX-6) Chemotherapy for Advanced Triple Negative Breast Cancer

Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
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Nearest Location:
374 miles
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, CA

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Visits:
Every 3 weeks for 4.5 months

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ClinicalTrials.gov: NCT07064018

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Phase I-II

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