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:
--Are diagnosed with breast cancer
--Have completed chemotherapy or surgery.
--Are diagnosed with breast cancer
--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:
-Get the study vaccine (ESR1 peptide)
-Return to the Duke Cancer Center for follow-up visits 6-8 times over 10 weeks.
-Be contacted by phone every 12 weeks to see how you are doing
-Have a skin biopsy (piece of skin will be taken) where the study vaccine was injected.
-Get the study vaccine (ESR1 peptide)
-Return to the Duke Cancer Center for follow-up visits 6-8 times over 10 weeks.
-Be contacted by phone every 12 weeks to see how you are doing
-Have a skin biopsy (piece of skin will be taken) where the study vaccine was injected.
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 ACCRUAL