STUDY BASICS
Are you post-menopausal, with ductal carcinoma in situ (DCIS) and expect to receive standard treatment for your DCIS? You may be eligible for a research study evaluate how immune systems (the part of your body that fights diseases) responds to an experimental treatment versus standard of care treatment. Compensation is provided.
STUDY PURPOSE
The main goal of this research study is to evaluate how immune systems (the part of your body that fights diseases) responds to an experimental treatment versus standard of care treatment.
COULD THIS STUDY BE RIGHT FOR YOU?
- woman 18 years of age or older
- are post-menopausal
- have ductal carcinoma in situ (DCIS) and expect to receive standard treatment for their DCIS.
WHAT PARTICIPANTS CAN EXPECT
You will be randomized to one of 2 groups:
An experimental group that consists of:
- A vaccine made of a MUC1 peptide and poly-ICLC together with,
- Standard treatment for breast DCIS that includes surgery with or without radiation, and
- An estrogen blocking drug. Your DCIS expresses the estrogen receptor, which means that estrogen blocking drugs that prevent estrogen from reaching your DCIS may help decrease its growth.
OR
A control group that will get:
- Standard treatment for breast DCIS that includes surgery with or without radiation, and
- An estrogen blocking drug. Your DCIS expresses the estrogen receptor, which means that estrogen blocking drugs that prevent estrogen from reaching your DCIS may help decrease its growth. The difference between the two groups is receiving the vaccine. You have a 66% chance of being assigned to the vaccine group.
IRB: STUDY21120156
- HCC 21-208: A Clinical Study of a Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In SituMEET THE RESEARCHER
Emilia Diego
Emilia Diego, MD, is an assistant professor in the Department of Surgery at Magee-Womens Hospital of UPMC. She specializes in premenopausal breast cancer, breast conservation therapy, locally advanced breast cancer, and high-risk breast disease.
Dr. Diego is board-certified in surgery and received her medical degree from the University of the Philippines College of Medicine, Manila, Philippines. She completed a residency in general surgery at Mercy Catholic Medical Center in Darby, Pa., and a surgical breast oncology fellowship at the University of Pittsburgh School of Medicine.
Dr. Diego is a member of the Society of Surgical Oncology, American Society of Breast Surgery, American Society of Clinical Oncology, American College of Surgeons, and the Association of Women Surgeons.