Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-03 @ 3:38 PM
Study NCT ID:
NCT03161834
Status:
WITHDRAWN
Last Update Posted:
2021-05-21
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
LCCC 1642: Plasma Circulating Tumor DNA (ctDNA) Analyses in ER+ Metastatic Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB Study Closure
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 study is to evaluate whether increased mutant ESR1 allele fraction in plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of progression free survival in patients with ER+ metastatic breast cancer.
Detailed Description:
The primary objective of this 110 patient correlative biomarker study is to evaluate whether changes in mutant ESR1 allele fraction in plasma circulating tumor DNA (ctDNA) are predictive of progression-free survival in metastatic ER+ breast cancer patients who are receiving 2nd, 3rd, or 4th line systemic endocrine therapy. A secondary goal of this study is to explore the prevalence and kinetics of hotspot and non-hotspot ctDNA ESR1 mutations in this patient population, prior to initiating a new line of endocrine therapy as well as upon clinical progression, to identify potential mechanisms of resistance. Although initially to be opened at UNC Chapel Hill, our goal is to expand enrollment to include Rex Cancer Center in Raleigh, North Carolina, and collaborating institutions through the Translational Breast Cancer Research Consortium.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 16-2952 | OTHER | UNC IRB | View |