Purpose of this Study
We are doing this study to find out if a new vaccine (ESR1 peptides) is safe and if they will help people with estrogen receptor positive (ER+) breast cancer.
Who Can Participate?
Eligibility
Adults who:<ul>
<li>Are diagnosed with breast cancer
<li>Have completed chemotherapy or surgery
<li>Are diagnosed with breast cancer
<li>Have completed chemotherapy or surgery
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study you will:<ul>
<li>Get the study vaccine (ESR1 peptide)</li>
<li>Return to the Duke Cancer Center for follow-up visits 6-8 times over 10 weeks</li>
<li>Be contacted by phone every 12 weeks to see how you are doing</li>
<li>Have a skin biopsy (piece of skin will be taken) where the study vaccine was injected</li>
<li>Get the study vaccine (ESR1 peptide)</li>
<li>Return to the Duke Cancer Center for follow-up visits 6-8 times over 10 weeks</li>
<li>Be contacted by phone every 12 weeks to see how you are doing</li>
<li>Have a skin biopsy (piece of skin will be taken) where the study vaccine was injected</li>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase I Study of Cancer Peptides plus GM-CSF and Adjuvant Following Completion of Prescribed Systemic Therapy of Estrogen Receptor Positive Breast Cancer
Study Website
Principal Investigator
Michael
Morse
Protocol Number
PRO00104868
NCT ID
NCT04270149
Phase
I
Enrollment Status
Open to Enrollment