Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-24 @ 10:07 PM
Study NCT ID:
NCT03719495
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2018-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Endocrine Therapy Effects of Host Immunity in Early Stage Breast Cancer
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Evaluation of the Effects of Endocrine Therapies on Immune Cell Repertoire and Function in Early Stage Estrogen Receptor Positive Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to learn about the effects that standard of care endocrine therapies have on the immune system's response to cancer by looking at the number and types of immune cells present and how they function in women with early stage estrogen receptor positive (ER+) breast cancer.
Detailed Description:
The study will enroll mainly subjects with estrogen receptor positive breast cancer that have completed surgery and radiation therapy to remove the tumor(s) and have not yet started standard treatment endocrine therapy. There is one group of subjects who have not been diagnosed with cancer. The information learned from this study will help doctors understand more about how the immune system responds to endocrine therapy for early stage breast cancer in people who are estrogen receptor positive with the goal of developing improved therapies that harness the immune system.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: