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(Last updated: October 21, 2020)

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1

NEAREST SITE: 353 miles
City of Hope Comprehensive Cancer Center
Duarte,CA

VISITS: Monthly visits, ongoing

PHASE: II

NCT ID: NCT03012100

Vaccine and Chemotherapy to Prevent Recurrence in Women With Stage I-III Triple Negative or ER-Low, HER2- Breast Cancer

Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer Scientific Title

Purpose
To compare the safety and effects (good and bad) of giving the chemotherapy cyclophosphamide (Cytoxan®) alone to giving it with an experimental vaccine.
Who is this for?
Women with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer.    Full eligibility criteria
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  • <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">Cyclophosphamide (Cytoxan®), by mouth, daily (every other week), for 1 month </li> <li class="seamTextUnorderedListItem">followed by vaccine and sargramostim, by injection, monthly, for 6 months, then every 6 months, for about 5 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan), by mouth, daily (every other week), for 1 month </li> <li class="seamTextUnorderedListItem">followed by placebo and sargramostim, by injection, monthly, for 6 months, then every 6 months, for about 5 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The experimental vaccine used in this trial is called a FR alpha peptide vaccine. It is a personalized vaccine made by removing some of your white blood cells and mixing them in a lab with tumor proteins. </li> <li class="seamTextUnorderedListItem">The vaccine is a type of immunotherapy--it may help your immune system to find and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Sargramostim (GM-CSF) helps prevent neutropenia--a low white blood cell count that increases your risk for infection.</li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low, HER2 negative breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03012100' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/immunotherapy/what' target='_blank'>Breastcancer.org: What is Immunotherapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>
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